Page last updated: 2024-12-06

terlipressin

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Description

Terlipressin is a synthetic analog of vasopressin, a naturally occurring hormone that constricts blood vessels and promotes water reabsorption in the kidneys. It is synthesized by modifying the amino acid sequence of vasopressin, specifically by replacing the phenylalanine residue at position 3 with ornithine. This modification enhances the vasoconstrictive properties of the compound, making it more potent than vasopressin. Terlipressin is used clinically to treat a variety of conditions, including esophageal variceal bleeding, acute liver failure, and septic shock. Its vasoconstrictive effects help to reduce bleeding from varices, improve blood pressure in patients with liver failure, and maintain hemodynamic stability in septic shock. Terlipressin's mechanism of action involves binding to V1A receptors in the vascular smooth muscle, leading to vasoconstriction. It also binds to V2 receptors in the kidneys, promoting water reabsorption. The therapeutic benefits of terlipressin are attributed to its potent vasoconstrictive and antidiuretic effects. Researchers are actively investigating the potential uses of terlipressin in other conditions, such as portal hypertension and hepatorenal syndrome. Terlipressin is a promising therapeutic agent with a wide range of applications in critical care medicine.'

terlivaz: first FDA approved injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID72081
CHEMBL ID2135460
CHEBI ID135905
SCHEMBL ID22699
MeSH IDM0058831

Synonyms (59)

Synonym
terlipressin acetate
terlipressin (usan/inn)
D06672
lucassin (tn)
14636-12-5
DB02638
terlipressin ,
n-(n-(n-glycylglycyl)glycyl)-8-l-lysinevasopressin
terlipressine [inn-french]
terlipressinum [inn-latin]
einecs 238-680-8
terlipressina [inn-spanish]
CHEBI:135905
(2s)-1-[(4r,7s,10s,13s,16s,19r)-19-[[2-[[2-[(2-aminoacetyl)amino]acetyl]amino]acetyl]amino]-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl
glycylpressin
triglycylvasopressin
triglycyl lysine vasopressin
glypressin
tglvp
terlypressin
NCGC00185754-01
dtxcid0028878
cas-14636-12-5
tox21_113374
dtxsid7048952 ,
CHEMBL2135460
AKOS015994637
unii-7z5x49w53p
terlipressin [usan:inn:ban]
terlipressinum
7z5x49w53p ,
terlipressine
terlipressina
lucassin
SCHEMBL22699
HS-2028 ,
(2s)-6-amino-2-{[(2s)-1-{[(4r,7s,10s,13s,16s,19r)-19-{2-[2-(2-aminoacetamido)acetamido]acetamido}-13-benzyl-10-(2-carbamoylethyl)-7-(carbamoylmethyl)-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbo
CS-5769
HY-12554
gtpl11241
variquel
J-008213
gly-gly-gly-cys-tyr-phe-gln-asn-cys-pro-lys-gly-nh2 (4-9 disulfide)
vasopressin, n-(glycylglycylglycyl)-8-l-lysine-
terlivaz
glycylglycylglycyl(8-l-lysine)vasopressin
Q324147
AMY25370
EX-A3116
CCG-270662
C72780
terlipressin (mart.)
terlipresina
h01ba04
terlipressina (inn-spanish)
terlipressin (ep monograph)
terlipressinum (inn-latin)
terlipressine (inn-french)
n-(n-(n-glycylglycyl)glycyl)-l-lysinevasopressin

Research Excerpts

Overview

Terrlipressin is a synthetic vasopressin analog which has been recently approved in the United States by the Food and Drug Administration for the treatment of hepatorenal syndrome. It induces selective vasoconstriction by stimulating the vasopressedin V1 receptors that are predominantly located in the splanchnic tissues.

ExcerptReferenceRelevance
"Terlipressin is an efficacious vasoconstrictor that has been used for 2 decades as the first-line treatment for HRS-AKI in Europe and has demonstrated greater efficacy in improving renal function compared to placebo and other vasoconstrictors."( Respiratory events with terlipressin and albumin in hepatorenal syndrome: A review and clinical guidance.
Allegretti, AS; Cárdenas, A; Francoz, C; Olson, JC; Subramanian, RM, 2022
)
1.75
"Terlipressin is a synthetic vasopressin analog which has been recently approved in the United States by the Food and Drug Administration for the treatment of hepatorenal syndrome. "( Terlipressin in the management of liver disease.
Martin, P; Scheinberg, AR; Turkeltaub, JA,
)
3.02
"Terlipressin is a value-based treatment option for appropriate adults with HRS with rapid reduction in kidney function."( Treatment-Related Cost Analysis of Terlipressin for Adults with Hepatorenal Syndrome with Rapid Reduction in Kidney Function.
Bindra, J; Chopra, I; Huang, X; Niewoehner, J; Wan, GJ, 2023
)
1.91
"Terlipressin is a cost-effective, value-based treatment option for appropriate adults with hepatorenal syndrome with rapid reduction in kidney function."( Treatment-Related Cost Analysis of Terlipressin for Adults with Hepatorenal Syndrome with Rapid Reduction in Kidney Function.
Bindra, J; Chopra, I; Huang, X; Niewoehner, J; Wan, GJ, 2023
)
1.91
"Terlipressin is a synthetic analogue of vasopressin and is safer than arginine vasopressin; it induces selective vasoconstriction by stimulating the vasopressin V1 receptors that are predominantly located in the splanchnic tissues."( Severe hyponatraemia with neurological manifestations in patients treated with terlipressin: Two case reports.
Dang, X; Li, L; Liu, Z; Meng, Q; Wang, H, 2019
)
1.46
"Terlipressin is a commonly used drug in hepatology practice for the two most serious complications of cirrhosis, that is, acute oesophageal variceal bleed and hepatorenal syndrome. "( Terlipressin-induced ischaemic skin necrosis.
Kulkarni, AV; Kumar, P; Rao, NP; Reddy, N, 2020
)
3.44
"Terlipressin (TP) is a synthetic vasopressin analogue used in the management of patients with septic shock."( Terlipressin for the treatment of septic shock in adults: a systematic review and meta-analysis.
Chang, W; Huang, L; Liu, S; Qiu, H; Xia, F; Yang, Y; Zhang, S, 2020
)
2.72
"Terlipressin is an effective drug for HRS reversal in patients with liver cirrhosis and acute-on-chronic liver failure."( Terlipressin has stood the test of time: Clinical overview in 2020 and future perspectives.
Arab, JP; Benítez, C; Kulkarni, AV; Kumar, P; Premkumar, M; Rao, PN; Reddy, DN; Sharma, M; Simonetto, DA; Tirumalige Ravikumar, S, 2020
)
2.72
"Terlipressin is a drug approved in Europe for treatment of HRS-AKI and supported by recommendations for first-line therapy by some liver societies and experts around the world."( The Current Management of Hepatorenal Syndrome-Acute Kidney Injury in the United States and the Potential of Terlipressin.
Brown, K; Brown, RS; Burra, P; Flamm, SL; Kugelmas, M; Poordad, F; Saab, S; Samaniego-Picota, M; Wadei, HM, 2021
)
1.56
"Terlipressin is an analogue of vasopressin that has potent vasoactive properties and has been available for use in most countries for nearly two decades. "( Terlipressin: Current and emerging indications in chronic liver disease.
Gow, P; Papaluca, T, 2018
)
3.37
"Terlipressin is a drug that increases the blood flow to the kidneys by constricting blood vessels."( Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome.
Allegretti, AS; Gluud, LL; Goldin, AH; Israelsen, M; Jovani, M; Krag, A; Schulman, AR; Winter, RW, 2017
)
2.62
"Terlipressin is a triglycyl-lysine vasopressin, a synthetic vasopressin analogue that is mainly used for the treatment of acute variceal hemorrhage."( [An evidence-based terlipressin therapy for gastroesophageal variceal hemorrhage].
Jia, JD; Qi, XS; Zhou, XM, 2018
)
1.53
"Terlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation where it causes vasoconstriction with subsequent reduction of blood loss during abdominal surgeries."( Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial.
Abbas, AM; Abbas, MS; Elawamy, A; Fadel, BA; Ibraheem, TM; Ibraheim, OA; Mohamed, KS; Taha, AM, 2019
)
1.63
"Terlipressin, in general, is a vasopressor which acts via V1 receptors. "( Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial.
Abbas, MS; Fadel, BA; Geddawy, M; Hassan, R; Hassan, SA; Herdan, R; Ibraheem, TM; Ibraheim, OA; Kamel, EZ; Mahdy, MM; Mostafa, MF; Sayed, JA; Taha, AM, 2019
)
2.35
"Terlipressin (TP) is a vasopressin analogue used to reverse certain shock etiologies in some European countries."( Terlipressin with limited fluid resuscitation in a swine model of hemorrhage.
Bielawski, A; DeVito, SS; Devlin, JJ; Gutierrez, MA; Henao, J; Johnson, AS; Kotora, J; Littlejohn, LF; Nowak, G, 2013
)
2.55
"Terlipressin is a synthetic vasopressin analogue that is used in the treatment of bleeding esophageal varices and hepatorenal syndrome in patients with cirrhosis. "( Ischemic skin necrosis following terlipressin therapy: report of two cases and review of the literature.
Aytan, P; Erdemır, F; Kisacik, B; Köseoğlu, RD; Kutlutürk, F; Taşliyurt, T; Yelken, BM; Yilmaz, A, 2012
)
2.1
"Terlipressin is a vasopressin analogue. "( [Severe hyponatraemia to terlipressin treatment].
Krag, A; Poulsen, A, 2013
)
2.14
"Terlipressin is a vasopressin analogue that is widely used in the treatment of hepatorenal syndrome or variceal bleeding. "( Severe ischemic bowel necrosis caused by terlipressin during treatment of hepatorenal syndrome.
Choi, JH; Choung, RS; Hyun, JJ; Jung, SW; Kim, HR; Koo, JS; Lee, HJ; Lee, SJ; Lee, SW; Lee, YS; Ryu, JY; Yim, HJ; Yoon, EL, 2013
)
2.1
"Terlipressin is a synthetic vasopressin analogue that is used in the treatment of bleeding esophageal varices and hepatorenal syndrome in patients with cirrhosis. "( Terlipressin-induced ischemic skin necrosis: a rare association.
Buğday, I; Gorkem, H; Karaman, A; Ozel Coskun, BD; Poyrazoğlu, OK; Senel, F, 2014
)
3.29
"Terlipressin is an analogue of vasopressin with a longer half-life that can be administered by bolus injection."( Comparison of normal saline, hypertonic saline albumin and terlipressin plus hypertonic saline albumin in an infant animal model of hypovolemic shock.
Bellón, JM; Botrán, M; Fernández, SN; García, A; González, R; López, J; López-Herce, J; Solana, MJ; Urbano, J, 2015
)
1.38
"Terlipressin is a synthetic vasopressin analogue that acts, via vascular vasopressin V1 receptors, as a systemic vasoconstrictor."( Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1.
Boyer, TD; Frederick, RT; Ganger, D; Jamil, K; Lake, JR; O'Leary, JG; Pappas, SC; Sanyal, AJ; Wong, F, 2016
)
2.6
"Terlipressin is a vasopressin analogue used for its vasoconstrictor effect in the treatment of variceal bleeding. "( Terlipressin Induced Severe Hyponatremia.
Paďour, F; Pokorný, M; Šíma, M; Slanař, O, 2016
)
3.32
"Terlipressin is a non-selective vasopressin analogue, exhibiting intrinsic agonist properties. "( Terlipressin, a vasoactive prodrug recommended in hepatorenal syndrome, is an agonist of human V1, V2 and V1B receptors: Implications for its safety profile.
Charrabi, A; Colson, PH; Corbani, M; Gaudard, P; Guillon, G; Manière, MJ; Richard, S; Virsolvy, A, 2016
)
3.32
"Terlipressin is a vasopressin analogue used in esophageal variceal bleeding and hepatorenal syndrome management. "( Cutaneous necrosis secondary to terlipressin therapy. A rare but serious side effect. Case report and literature review.
Badía Aranda, E; Bernad Cabredo, B; Corrales Cruz, D; Iglesias Julián, E; Romero Arauzo, MJ, 2017
)
2.18
"Terlipressin is a synthetic analogue of vasopressin, which has been used in the treatment of acute variceal hemorrhage. "( [A case of ischemic skin necrosis after glypressin therapy in liver cirrhosis].
Cho, DH; Ha, JS; Oh, JE; Shim, SG; Yu, GJ, 2008
)
1.79
"Terlipressin is an analog of the natural hormone arginine-vasopressin. "( Efficacy and safety of terlipressin in cirrhotic patients with variceal bleeding or hepatorenal syndrome.
Bendtsen, F; Borup, T; Krag, A; Møller, S, 2008
)
2.1
"Terlipressin is an effective pharmacologic treatment for hemobilia in patients with portal biliopathy."( Terlipressin in control of acute hemobilia during therapeutic ERCP in patient with portal biliopathy.
Agarwal, AK; Puri, AS; Sachdeva, S; Tyagi, P, 2009
)
2.52
"Terlipressin plus albumin is an effective treatment for type 1 hepatorenal syndrome (HRS), but approximately only half of the patients respond to this therapy. "( Predictors of response to therapy with terlipressin and albumin in patients with cirrhosis and type 1 hepatorenal syndrome.
Arroyo, V; Baccaro, ME; Ginès, P; Guevara, M; Marinelli, M; Martín-Llahi, M; Nazar, A; Pepin, MN; Pereira, GH; Solá, E; Terra, C, 2010
)
2.07
"Terlipressin is a splanchnic constrictor that is used to control variceal bleeding and is considered to have a very good safety profile compared to vasopressin. "( Terlipressin-induced hyponatremic seizure.
Chun, HJ; Hyun, JJ; Jeen, YT; Keum, B; Kim, CD; Lee, KG; Ryu, HS; Seo, YS; Um, SH; Yim, HJ, 2010
)
3.25
"Terlipressin is a potential therapeutic option for HRS, but larger trials comparing terlipressin to other widely used vasoconstrictors are warranted."( Terlipressin in hepatorenal syndrome: a systematic review and meta-analysis.
Demirjian, S; Dobre, M; Navaneethan, SD; Sehgal, AR, 2011
)
2.53
"Terlipressin (TP) is a potent vasoconstrictor, which is widely used in the treatment of bleeding esophageal varices and the hepatorenal syndrome. "( Effects of a single dose of terlipressin on transcutaneous oxygen pressures.
Bendtsen, F; Henriksen, JH; Krag, A; Møller, S, 2010
)
2.1
"Terlipressin is a vasopressin analogue used for its potent V1a effects in cirrhotic patients. "( Effects of the vasopressin agonist terlipressin on plasma cAMP and ENaC excretion in the urine in patients with cirrhosis and water retention.
Bendtsen, F; Krag, A; Møller, S; Pedersen, EB, 2011
)
2.09
"Terlipressin is a vasopressin analogue that has also been studied."( [Septic shock. Update of treatment using hypertonic saline and antidiuretic hormone-vasopressin].
Aguirre Sánchez-Covisa, M; Araujo, F; Bocharán, S; Collar, LG; Gil Trujillo, S; Pascual-Ramírez, J,
)
0.85
"Terlipressin is a synthetic analog of vasopressin characterized by greater selectivity for the V1 receptor than vasopressin."( Terlipressin in brain-death donors.
De Robertis, E; Iannuzzi, M; Piazza, O; Rispoli, F; Scarpati, G; Tufano, R,
)
2.3
"Terlipressin appears to be an effective drug for the treatment of ascites due to liver cirrhosis in a rat model, possibly due to AQP2 reduction in kidneys."( Terlipressin resolves ascites of cirrhotic rats through downregulation of aquaporin 2.
Bai, CX; He, BM; Huang, YY; Sun, JY; Wang, JY, 2012
)
2.54
"Terlipressin is a safe and effective treatment for acute oesophageal variceal bleeding, with or without adjuvant endoscopic sclerotherapy. "( Systematic review: terlipressin in acute oesophageal variceal haemorrhage.
Doust, J; Ioannou, GN; Rockey, DC, 2003
)
2.09
"Terlipressin is a vasopressin analog that may improve renal function in hepatorenal syndrome by mechanisms as yet unknown. "( Systemic, portal and renal effects of terlipressin in patients with cirrhotic ascites: pilot study.
Hayes, PC; Stanley, AJ; Therapondos, G, 2004
)
2.04
"Terlipressin is a promising investigational medication for treatment of septic shock. "( Terlipressin: vasopressin analog and novel drug for septic shock.
Jennings, HR; Pesaturo, AB; Voils, SA, 2006
)
3.22
"Terlipressin is a long-acting vasopressin analogue that has been proved useful in the treatment of variceal haemorrhage. "( Time profile of the haemodynamic effects of terlipressin in portal hypertension.
Bandi, JC; Bosch, J; Escorsell, A; Feu, F; García-Pagan, JC; Moitinho, E; Rodés, J, 1997
)
2
"Terlipressin seems to be an effective rescue therapy, which is able to restore blood pressure in patients with catecholamine-resistant septic shock, without obvious complication."( Terlipressin for norepinephrine-resistant septic shock.
Clapp, L; O'Brien, A; Singer, M, 2002
)
2.48
"Terlipressin (Glypressin) is a "pro-hormone"; after intravenous injection the glycyl radicals are slowly cleaved by enzymatic action, liberating vasopressin. "( [Treatment of severe hemoptysis with terlipressin. Study of the efficacy and tolerance of this product].
D'Odemont, JP; Derollez, M; Ramon, P; Tonnel, AB; Wallaert, B, 1989
)
1.99

Effects

Terrlipressin has been shown to improve both pulmonary and systemic hemodynamics in stable cirrhotic patients with pulmonary hypertension. It has longer effects and is more effective and safer than vasopressin alone or in combination with nitroglycerin.

ExcerptReferenceRelevance
"Terlipressin (Terlivaz) has been approved as the first drug to treat hepatorenal syndrome.The drug may cause serious or fatal respiratory failure. "( First Drug for Treating Hepatorenal Syndrome.
Aschenbrenner, DS, 2023
)
2.35
"Terlipressin has been widely used as a renoprotective agent during the perioperative period of LT."( Prophylactic terlipressin infusion for severe postreperfusion syndrome in patients undergoing deceased donor liver transplantation: the TIPS-DDLT randomized controlled trial.
Sun, LY; Tian, M; Zhang, L; Zhu, ZJ, 2023
)
2
"Terlipressin has been shown to be effective in controlling variceal bleeding and decreasing associated mortality. "( Severe hyponatraemia with neurological manifestations in patients treated with terlipressin: Two case reports.
Dang, X; Li, L; Liu, Z; Meng, Q; Wang, H, 2019
)
2.18
"Terlipressin has demonstrated its usefulness in other pediatric critical care scenarios and its long half-life allows its use as a bolus in an outpatient critical settings."( Addition of terlipressin to initial volume resuscitation in a pediatric model of hemorrhagic shock improves hemodynamics and cerebral perfusion.
Galbarriatu, L; Gil-Anton, J; López-Fernández, Y; Mielgo, VE; Morteruel, E; Redondo, S; Rey-Santano, C; Santos, C; Unceta, M, 2020
)
1.66
"Terlipressin has not been considered as the mainstay treatment option for ascites in cirrhosis yet."( Role of Terlipressin in Cirrhotic Patients with Ascites and without Hepatorenal Syndrome: A Systematic Review of Current Evidence.
An, Y; Bai, Z; Guo, X; Li, H; Méndez-Sánchez, N; Qi, X; Teschke, R, 2020
)
1.71
"Terlipressin has long term survival benefits perhaps at least up to three months but only with HRS as a cause of death not for other causes of death. "( Survival benefits of terlipressin and non-responder state in hepatorenal syndrome: a meta-analysis.
Hiremath, SB; Srinivas, LD,
)
1.89
"Terlipressin has been used commonly; however, it is costly and not available in some countries."( Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study.
Agarwal, R; Bhalla, A; Chawla, YK; Choudhary, NS; Ghosh, S; Kumar, P; Sharma, AK; Sharma, N; Singh, B; Singh, V, 2013
)
1.45
"Terlipressin has been shown to be effective in the management of sepsis-induced hypotension and hepatorenal syndrome and recently has been tried as infusion during liver transplantation."( Effect of perioperative terlipressin infusion on systemic, hepatic, and renal hemodynamics during living donor liver transplantation.
Alwaraqy, M; Fayed, N; Refaat, EK; Yassein, TE, 2013
)
1.42
"Terlipressin has generally been considered standard treatment, but noradrenaline has been postulated as alternative."( Noradrenaline or terlipressin for hepatorenal syndrome?
Celis, P; Rada, G, 2015
)
1.48
"Terlipressin has been shown to be effective in treatment of HRS."( Noradrenaline is as Effective as Terlipressin in Hepatorenal Syndrome Type 1: A Prospective, Randomized Trial.
Goyal, O; Puri, S; Sehgal, N; Sidhu, SS, 2016
)
1.44
"Terlipressin has been proposed as an alternative treatment to catecholamines to restore blood pressure in septic shock. "( Terlipressin, a provasopressin drug exhibits direct vasoconstrictor properties: consequences on heart perfusion and performance.
Colson, PH; Fort, A; Guillon, G; Murat, B; Richard, S; Ryckwaert, F; Virsolvy, A, 2009
)
3.24
"Terlipressin has been shown to be effective in the management of hepatorenal syndrome. "( Effects of terlipressin on systemic, hepatic and renal hemodynamics in patients with cirrhosis.
Atsukawa, M; Fukuda, T; Harimoto, H; Kanazawa, H; Katakura, T; Kidokoro, H; Kimura, Y; Matsushita, Y; Nakatsuka, K; Narahara, Y; Sakamoto, C; Taki, Y, 2009
)
2.19
"Terlipressin has been successfully used as rescue treatment in hypotensive adults and children with septic shock, but only exceptionally in neonates. "( Rescue treatment with terlipressin in different scenarios of refractory hypotension in newborns and infants.
Catarzi, S; Daniotti, M; Filippi, L; Fiorini, P; Gozzini, E; Pagliai, F, 2011
)
2.13
"Terlipressin has been associated with pulmonary arterial vasodilation in patients with pulmonary hypertension (PH). "( Differential effects of terlipressin on pulmonary and systemic hemodynamics in patients with cirrhosis and pulmonary hypertension: an echo study.
Kalambokis, GN; Pappas, K; Tsianos, EV, 2012
)
2.13
"Terlipressin has been shown to improve both pulmonary and systemic hemodynamics in stable cirrhotic patients with pulmonary hypertension, whereas other vasoconstrictors may cause pulmonary pressures to deteriorate. "( Terlipressin improves pulmonary pressures in cirrhotic patients with pulmonary hypertension and variceal bleeding or hepatorenal syndrome.
Kalambokis, GN; Pappas, K; Tsianos, EV, 2012
)
3.26
"Terlipressin has been proposed to treat renal failure in patients with type 1 hepatorenal syndrome (HRS). "( Clinical course, predictive factors and prognosis in patients with cirrhosis and type 1 hepatorenal syndrome treated with Terlipressin: a retrospective analysis.
Barrière, E; Bernuau, J; Colle, I; Durand, F; Lebrec, D; Moreau, R; Pessione, F; Rassiat, E; Valla, DC, 2002
)
1.96
"Terlipressin has been suggested as the ideal drug to treat anesthesia-induced hypotension in patients under long-term renin-angiotensin system inhibitor treatment for arterial hypertension. "( Terlipressin versus norepinephrine to counteract anesthesia-induced hypotension in patients treated with renin-angiotensin system inhibitors: effects on systemic and regional hemodynamics.
Conti, G; De Gaetano, A; Morelli, A; Orecchioni, A; Pelaia, P; Picchini, U; Pietropaoli, P; Reale, C; Rocco, M; Tritapepe, L, 2005
)
3.21
"Terlipressin has recently been shown in an animal model of cirrhosis to suppress endotoxin-induced TNF-alpha-mediated upregulation of iNOS, thereby preventing overproduction of nitric oxide and restoring normal vascular tone."( Nitric-oxide-lowering effect of terlipressin in decompensated cirrhosis: comparison to the molecular adsorbent recirculating system and correlation with clinical status.
Bihari, D; Boyle, M; Kurtovic, J; Riordan, SM, 2004
)
1.33
"Terlipressin has longer effects and is more effective and safer than vasopressin alone or in combination with nitroglycerin."( The sixth Carlos E. Rubio Memorial Lecture. Prevention and treatment of variceal hemorrhage.
Bosch, J, 2000
)
1.03

Actions

Terlipressin produced an increase in mean arterial pressure and a decrease in gastric mucosal perfusion detected by laser Doppler flowmetry over 30 min. The ter Lipressin-induced increase in urine output was associated with a significantly increased creatinine clearance ( p<0.05).

ExcerptReferenceRelevance
"The terlipressin-induced increase in urine output was associated with a significantly increased creatinine clearance ( p<0.05)."( Effects of terlipressin on systemic and regional haemodynamics in catecholamine-treated hyperkinetic septic shock.
Coluzzi, F; Conti, G; Cortese, G; De Gaetano, A; Morelli, A; Orecchioni, A; Pelaia, P; Pietropaoli, P; Rocco, M; Vernaglione, E, 2004
)
1.19
"Terlipressin produced an increase in mean arterial pressure and a decrease in gastric mucosal perfusion detected by laser Doppler flowmetry (P < 0.05) over 30 min that were sustained for 4 h. "( Terlipressin versus norepinephrine to counteract anesthesia-induced hypotension in patients treated with renin-angiotensin system inhibitors: effects on systemic and regional hemodynamics.
Conti, G; De Gaetano, A; Morelli, A; Orecchioni, A; Pelaia, P; Picchini, U; Pietropaoli, P; Reale, C; Rocco, M; Tritapepe, L, 2005
)
3.21
"Terlipressin seems to cause no adverse effect but warrants further evaluation as a rescue therapy in refractory septic shock."( Terlipressin as a rescue therapy for catecholamine-resistant septic shock in children.
Alhan, E; Celik, U; Sertdemir, Y; Yapicioglu, H; Yildizdas, D, 2008
)
2.51

Treatment

Terlipressin-treated animals had significantly higher angiotensin II type 1 receptor expression and normalization of arginine vasopressin 1a receptor expression. Ter Lipressin treatment is superior to placebo for achieving HRS1 reversal, but mortality benefit is less clear.

ExcerptReferenceRelevance
"In terlipressin-treated animals, there was also significantly higher angiotensin II type 1 receptor expression and normalization of arginine vasopressin 1a receptor expression."( Terlipressin combined with conservative fluid management attenuates hemorrhagic shock-induced acute kidney injury in rats.
Andrade, L; Castro, LUC; da Silva, C; Duarte-Neto, AN; Gomes, SA; Malbouisson, LS; Noronha, IL; Otsuki, DA; Sanches, TR; Santinho, MAR; Souza, FL, 2022
)
2.68
"Terlipressin-treated patients with HRS-1, with a lower baseline serum creatinine level, had a higher overall survival (p<0.001) and higher transplant-free survival at Day 90 (p=0.04)."( Early treatment with terlipressin in patients with hepatorenal syndrome yields improved clinical outcomes in North American studies.
Befeler, AS; Curry, MP; Jamil, K; Patwardhan, VR; Pyrsopoulos, NT; Vargas, HE, 2023
)
1.95
"More terlipressin-treated patients who were listed for and received a liver transplant were alive and RRT-free by Day 90."( Terlipressin in combination with albumin as a therapy for hepatorenal syndrome in patients aged 65 years or older.
Gamilla-Crudo, AK; Hussain, SA; Jamil, K; Karim, A; Khattak, MW; Kueht, M; Merwat, SN; Mujtaba, MA; Rooney, PJ,
)
2.03
"Terlipressin treatment is associated with improved renal function."( Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies.
Araya, V; Boyer, TD; Escalante, S; Frederick, RT; Jamil, K; Pappas, SC; Reddy, KR; Rossaro, L; Sanyal, AJ; Teuber, P; Vargas, HE; Wong, F, 2017
)
1.44
"A terlipressin treatment course seems to be justified in selected patients with HRS type 2, especially in countries and settings with long transplant waiting lists. "( Terlipressin and albumin combination treatment in patients with hepatorenal syndrome type 2.
Galle, PR; Jäger, J; Labenz, C; Marquardt, JU; Nagel, M; Nguyen-Tat, M; Rey, JW; Wörns, MA, 2019
)
2.68
"The terlipressin treated rats can maintain this restored level of MAP for 45 minutes, but the vasopressin treated rats can only maintain this restored level of MAP for 5 minutes before decreasing gradually to the MAP observed in LR group (40 mmHg)."( A comparison of vasopressin, terlipressin, and lactated ringers for resuscitation of uncontrolled hemorrhagic shock in an animal model.
Chang, SS; Chen, SC; Huang, YC; Lee, CC; Lee, MT; Lee, SH; Yo, CH, 2014
)
1.17
"Terlipressin treatment is superior to placebo for achieving HRS1 reversal, but mortality benefit is less clear. "( Systematic review with meta-analysis: vasoactive drugs for the treatment of hepatorenal syndrome type 1.
Fallowfield, JA; Gifford, FJ; Morling, JR, 2017
)
1.9
"Terlipressin treatment consisted of a loading dose (20 μg/kg) followed by continuous infusion at a rate of 4-20 μg/kg/h."( Continuous terlipressin infusion as rescue treatment in a case series of children with refractory septic shock.
Gaboli, M; Gil-Antón, J; López-Herce, J; Milano, G; Oulego-Erroz, I; Pérez-Caballero, C; Rodríguez-Núñez, A, 2010
)
1.47
"Terlipressin treatment of hypotension due to septic shock was successful in eight out of 16 episodes."( Terlipressin as rescue therapy for intractable hypotension due to septic shock in children.
Adam, M; Barzilay, Z; Efrati, O; Leibovitch, L; Matok, I; Paret, G; Rubinshtein, M; Vard, A; Vishne, T, 2005
)
2.49
"Treatment with terlipressin in patients with less severe acute kidney injury (serum creatinine <2.25 mg/dL) was associated with higher treatment responses, and 90-day survival."( Real-world treatment patterns and outcomes using terlipressin in 203 patients with the hepatorenal syndrome.
Allegretti, AS; Bakker, R; Corman, S; Heisen, M; Huang, X; Jamil, K; Kebede, N; Leonardi, R; Luo, L; Maï, C; Moore, K; Shamseddine, N; Verleger, K, 2020
)
1.15
"Treatment with terlipressin and albumin led to HRS1 reversal more frequently than albumin alone or placebo (RR: 2.54, 95% CI: 1.51-4.26)."( Systematic review with meta-analysis: vasoactive drugs for the treatment of hepatorenal syndrome type 1.
Fallowfield, JA; Gifford, FJ; Morling, JR, 2017
)
0.79
"Treatment with terlipressin has currently the best efficacy pedigree, inducing hepatorenal syndrome reversal in a high proportion of patients."( Midodrine in the prevention of hepatorenal syndrome type 2 recurrence: a case-control study.
Alessandria, C; Carello, M; Ceretto, S; Debernardi-Venon, W; Marzano, A; Rizzetto, M, 2009
)
0.69
"Treatment with terlipressin and albumin has been reported recently to be effective in improving renal function in the treatment of cirrhotic patients with hepatorenal syndrome (HRS). "( The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study.
Fukui, H; Kanazawa, H; Kokubu, S; Maruyama, H; Masaki, N; Matsuzaki, Y; Mochida, S; Narahara, Y; Okita, K; Sakamoto, C; Sumino, Y; Uemura, M; Yokosuka, O, 2012
)
1.03
"Treatment with terlipressin and albumin improves renal function in cirrhotic patients with type 1 HRS. "( The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study.
Fukui, H; Kanazawa, H; Kokubu, S; Maruyama, H; Masaki, N; Matsuzaki, Y; Mochida, S; Narahara, Y; Okita, K; Sakamoto, C; Sumino, Y; Uemura, M; Yokosuka, O, 2012
)
1.03
"Treatment with terlipressin and albumin was associated with a remarkable decrease in serum creatinine level, increase in arterial pressure, and suppression of the renin-aldosterone system."( Terlipressin therapy with and without albumin for patients with hepatorenal syndrome: results of a prospective, nonrandomized study.
Arroyo, V; Bataller, R; Calahorra, B; Cárdenas, A; De Las Heras, D; Ginès, P; Guevara, M; Jiménez, W; Ortega, R; Rodés, J; Uriz, J, 2002
)
2.1
"Treatment with terlipressin boluses (0.5 mg/4 h) associated with albumin infusion was then started."( Is spontaneous bacterial peritonitis an inducer of vasopressin analogue side-effects? A case report.
De Santis, A; Giorgi, A; Laviano, A; Riggio, O; Rossi-Fanelli, F; Vaccaro, F, 2003
)
0.66

Toxicity

Continuous terlipressin infusion is more effective than bolus administration in reducing HVPG at a lower dose with fewer adverse events in cirrhotic patients.

ExcerptReferenceRelevance
"Terlipressin associated with albumin appears to be a safe and effective treatment of hepatorenal syndrome."( Terlipressin plus albumin infusion: an effective and safe therapy of hepatorenal syndrome.
Arroyo, V; Bataller, R; Cárdenas, A; Ginès, P; Jiménez, W; Mas, A; Navasa, M; Rodés, J; Salmerón, JM; Sort, P; Uriz, J, 2000
)
3.19
"Terlipressin and Gelatinepolysuccinat appear to be a safe and effective treatment of hepatorenal syndrome."( Terlipressin and gelafundin: safe therapy of hepatorenal syndrome.
Biglarnia, R; Broelsch, CE; Frühauf, NR; Kavuk, I; Lang, H; Malagó, M; Saner, F; Schäfers, RF, 2004
)
3.21
"The study confirms that administration of terlipressin, by either Haemopressin or Glypressin, is generally safe and indeed highly effective in the treatment of acute EVH."( Open, randomized, comparative study of efficacy and safety between Haemopressin and Glypressin in treating acute esophageal varices hemorrhage.
Hu, RH; Lee, PH,
)
0.4
" Adverse events are mostly cardiovascular and related to vasoconstriction."( Efficacy and safety of terlipressin in cirrhotic patients with variceal bleeding or hepatorenal syndrome.
Bendtsen, F; Borup, T; Krag, A; Møller, S, 2008
)
0.66
" Complication of congestive heart failure possibly related to this regimen was seen in 1 patient, but ischemic adverse events were not observed during the treatment."( The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study.
Fukui, H; Kanazawa, H; Kokubu, S; Maruyama, H; Masaki, N; Matsuzaki, Y; Mochida, S; Narahara, Y; Okita, K; Sakamoto, C; Sumino, Y; Uemura, M; Yokosuka, O, 2012
)
0.68
" Therefore, the possible benefits of terlipressin should be always weighed against potential severe adverse effects."( Safety and Efficacy of Terlipressin in Pediatric Distributive Shock: A Retrospective Analysis in 20 Children.
Hofbeck, M; Kumpf, M; Michel, J; Neunhoeffer, F; Renk, H; Spiller, G, 2017
)
1.04
" It is a safe drug with mild secondary effects."( Cutaneous necrosis secondary to terlipressin therapy. A rare but serious side effect. Case report and literature review.
Badía Aranda, E; Bernad Cabredo, B; Corrales Cruz, D; Iglesias Julián, E; Romero Arauzo, MJ, 2017
)
0.74
" Adverse events, effects of treatment on renal function, model for end-stage liver disease (MELD) score, and paracentesis/thoracentesis requirements were assessed."( Safety and efficacy of outpatient continuous terlipressin infusion for the treatment of portal hypertensive complications in cirrhosis.
Angus, PW; Chapman, B; Gow, PJ; Sinclair, M; Terbah, R; Testro, AG; Thwaites, PA, 2022
)
0.98
" There were no cardiac or ischemic complications and no serious adverse events reported."( Safety and efficacy of outpatient continuous terlipressin infusion for the treatment of portal hypertensive complications in cirrhosis.
Angus, PW; Chapman, B; Gow, PJ; Sinclair, M; Terbah, R; Testro, AG; Thwaites, PA, 2022
)
0.98
"Transplant-eligible and otherwise stable patients can be managed with CTI at home for an extended duration under supervision without adverse consequences."( Safety and efficacy of outpatient continuous terlipressin infusion for the treatment of portal hypertensive complications in cirrhosis.
Angus, PW; Chapman, B; Gow, PJ; Sinclair, M; Terbah, R; Testro, AG; Thwaites, PA, 2022
)
0.98
" Our secondary outcomes will include (1) major neurosensory abnormality and (2) the occurrence of adverse events."( Efficacy and safety of vasopressin and terlipressin in preterm neonates: a protocol for a systematic review.
Alsaadi, AS; Bui, V; Razak, A; Samiee-Zafarghandy, S; Sushko, K; Van Den Anker, J, 2021
)
0.89
"Terlipressin with albumin, the recommended treatment for hepatorenal syndrome-acute kidney injury (HRS-AKI), is associated with adverse events."( Safety and efficacy of terlipressin in acute-on-chronic liver failure with hepatorenal syndrome-acute kidney injury (HRS-AKI): a prospective cohort study.
Gupta, R; Kulkarni, AV; Kumar, K; Premkumar, M; Rao, PN; Ravikumar, ST; Reddy, DN; Sharma, M; Tevethia, H, 2022
)
2.47
" This is a case report of a cirrhotic patient with nonvariceal upper gastrointestinal bleeding after duodenal necrosis due to the use of terlipressin, a novel side effect not yet described in literature to the best of our knowledge."( Duodenal Necrosis and Nonvariceal Digestive Bleeding After Terlipressin Administration for Treatment of Hepatorenal Syndrome: a Case Report of a Novel Side Effect of a Commonly Used Drug.
Andraus, W; Arantes, RM; Carneiro-D'albuquerque, LA; Cunha, MR; De Moura, EG; Ducatti, L; Ernani, L; Fernandes, MR; Galvão, FH; Martino, RB; Nacif, LS; Pereira, PB; Pinheiro, RS; Rocha-Santos, V; Waisberg, DR, 2022
)
1.17
" Given its fatality potential, this novel side effect should be remembered when using this medication in cirrhotic patients."( Duodenal Necrosis and Nonvariceal Digestive Bleeding After Terlipressin Administration for Treatment of Hepatorenal Syndrome: a Case Report of a Novel Side Effect of a Commonly Used Drug.
Andraus, W; Arantes, RM; Carneiro-D'albuquerque, LA; Cunha, MR; De Moura, EG; Ducatti, L; Ernani, L; Fernandes, MR; Galvão, FH; Martino, RB; Nacif, LS; Pereira, PB; Pinheiro, RS; Rocha-Santos, V; Waisberg, DR, 2022
)
0.96
" Hyponatremia was the most frequently reported adverse event (n = 37, 25%)."( Efficacy and Safety of Vasopressin and Terlipressin in Preterm Neonates: A Systematic Review.
Al-Saadi, A; Bui, V; Razak, A; Samiee-Zafarghandy, S; Sushko, K; van den Anker, J, 2022
)
0.99
" This approach in cirrhosis patients with acute esophageal variceal bleed was investigated by comparing the efficacy and adverse events of continuous versus bolus administration of terlipressin."( Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding.
Arora, V; Choudhary, SP; Jindal, A; Kumar, G; Maiwall, R; Sarin, SK; Vijayaraghavan, R, 2023
)
1.43
"001)} and adverse events were fewer {20/55(36."( Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding.
Arora, V; Choudhary, SP; Jindal, A; Kumar, G; Maiwall, R; Sarin, SK; Vijayaraghavan, R, 2023
)
1.23
""HVPG-tailored" continuous terlipressin infusion is more effective than bolus administration in reducing HVPG at a lower dose with fewer adverse events in cirrhotic patients."( Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding.
Arora, V; Choudhary, SP; Jindal, A; Kumar, G; Maiwall, R; Sarin, SK; Vijayaraghavan, R, 2023
)
1.53

Pharmacokinetics

ExcerptReferenceRelevance
" The half-life of distribution and elimination was 8 and 50 min, respectively."( Pharmacokinetics of terlipressin after single i.v. doses to healthy volunteers.
Berling, R; Lindblom, P; Nilsson, G; Ohlin, M; Vernersson, E, 1990
)
0.6
" Terlipressin has demonstrated its usefulness in other pediatric critical care scenarios and its long half-life allows its use as a bolus in an outpatient critical settings."( Addition of terlipressin to initial volume resuscitation in a pediatric model of hemorrhagic shock improves hemodynamics and cerebral perfusion.
Galbarriatu, L; Gil-Anton, J; López-Fernández, Y; Mielgo, VE; Morteruel, E; Redondo, S; Rey-Santano, C; Santos, C; Unceta, M, 2020
)
1.85

Compound-Compound Interactions

The aim of this study was to examine the systemic and splanchnic hemodynamic responses to terlipressin administered alone or combined with nitroglycerin in patients with cirrhosis.

ExcerptReferenceRelevance
" The aim of this study was to examine the systemic and splanchnic hemodynamic responses to terlipressin administered alone or combined with nitroglycerin in patients with cirrhosis."( [Hemodynamic effects of the administration of terlipressin alone or combined with nitroglycerin in patients with cirrhosis].
Gaudin, C; Hadengue, A; Kleber, G; Lebrec, D; Moreau, R; Sogni, P; Soubrane, O, 1992
)
0.76
"Objective: The objective of this study was to provide an in-depth analysis of the advantages and potential research directions concerning the utilization of terlipressin (TP) in combination with norepinephrine (NE) for the management of septic shock."( TERLIPRESSIN COMBINED WITH NOREPINEPHRINE IN THE TREATMENT OF SEPTIC SHOCK: A SYSTEMATIC REVIEW.
Liang, D; Lin, L; Mao, F; Tang, Z; Xu, Y, 2023
)
2.55

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The effects of a reduced dose (1 mg) were almost as pronounced and prolonged, suggesting that after the initial control of variceal bleeding, terlipressin therapy could be maintained for several days at low dosage to reduce the risk of early rebleeding. Future developments in dosage and administrative techniques may have an important role to play in maintaining clinical efficacy.

ExcerptRelevanceReference
"01) lower blood levels of 1 in contrast to bolus injection of 1 without 2 under identical dosage regimens."( [The effect of the vasoconstrictor glycylpressin on the bioavailability of mitomycin C].
Czejka, M; Jäger, W; Schüller, J, 1991
)
0.28
"In order to develop a method for selective radioprotection of the rectal mucosa, a dose-response study was carried out using triglycyl-lysine-vasopressin and lysine-vasopressin."( Determination of a suitable dosage of lysine-vasopressin and triglycyl-lysine-vasopressin, given in a gel-solution locally in the rectum of rats for possible radioprotective purposes.
Bjelkengren, G, 1990
)
0.28
" In order to determine an appropriate dosage of TGLVP in patients with burns, a dose-response study was undertaken."( The effect of triglycyl-lysine-vasopressin (terlipressin INN, Glypressin) on skin blood flow, measured with laser Doppler flowmetry, thermography and plethysmography. A dose-response study.
Aberg, M; Lindblom, P; Nilsson, G; Palmer, B; Vernersson, E, 1987
)
0.53
" Vasopressin dosing has also been a point of controversy."( Vasopressin therapy for upper gastrointestinal tract hemorrhage. Has its efficacy been proven?
Hussey, KP, 1985
)
0.27
") and oral administration of ronidazole in sheep (n = 6) at a dosage of 5 mg/kg body weight."( Plasma ronidazole concentrations in sheep after intravenous, oral, intraruminal and intraabomasal administration.
Debackere, M; Vynckier, LJ, 1993
)
0.29
" The effects of a reduced dose (1 mg) were almost as pronounced and prolonged, suggesting that after the initial control of variceal bleeding, terlipressin therapy could be maintained for several days at low dosage to reduce the risk of early rebleeding."( Time profile of the haemodynamic effects of terlipressin in portal hypertension.
Bandi, JC; Bosch, J; Escorsell, A; Feu, F; García-Pagan, JC; Moitinho, E; Rodés, J, 1997
)
0.76
" Due to the limited number of patients treated so far, it is, however, difficult to draw any definite conclusions on the optimal dosage and on the occurrence of side-effects in these patients."( Is spontaneous bacterial peritonitis an inducer of vasopressin analogue side-effects? A case report.
De Santis, A; Giorgi, A; Laviano, A; Riggio, O; Rossi-Fanelli, F; Vaccaro, F, 2003
)
0.32
"5 mg) to a patient with severe, hyperdynamic septic shock requiring high dosage of noradrenalin."( Terlipressin increased the concentration of L-lactate in the rectal lumen in a patient with septic shock.
Jørgensen, VL; Perner, A; Waldau, T, 2004
)
1.77
"To review and assess available literature on chemistry, pharmacology, pharmacodynamics, pharmacokinetics, clinical studies, adverse events, drug interactions, and dosing and administration of terlipressin in septic shock."( Terlipressin: vasopressin analog and novel drug for septic shock.
Jennings, HR; Pesaturo, AB; Voils, SA, 2006
)
1.97
" Further studies are needed to verify safety, efficacy, and dosing of terlipressin in patients with septic shock, and its use cannot be recommended in lieu of vasopressin at this time."( Terlipressin: vasopressin analog and novel drug for septic shock.
Jennings, HR; Pesaturo, AB; Voils, SA, 2006
)
2.01
"Randomized or quasi-randomized trials evaluating vasopressin or its analogues, at any dosage or duration used as an adjunct to standard therapy (any combination of volume expansion, inotropic agents and corticosteroids) to treat refractory hypotension in neonates."( Vasopressin and its analogues for the treatment of refractory hypotension in neonates.
Fernandes, CJ; Pammi, M; Rios, D; Rossano, J; Shivanna, B, 2013
)
0.39
" Median cumulative terlipressin dosage and treatment duration were 20 mg and 5 days, respectively."( [Response to Terlipressin and albumin is associated with improved outcome in patients with cirrhosis and hepatorenal syndrome].
Ahrens, J; Galle, PR; Götz, E; Marquardt, JU; Nguyen-Tat, M; Rey, JW; Schattenberg, J; Scholz-Kreisel, P; Sivanathan, V; Wörns, MA, 2015
)
1.11
" The hemodynamics of eight patients did not improve, regardless of treatment dosage or duration."( Safety and Efficacy of Terlipressin in Pediatric Distributive Shock: A Retrospective Analysis in 20 Children.
Hofbeck, M; Kumpf, M; Michel, J; Neunhoeffer, F; Renk, H; Spiller, G, 2017
)
0.77
" Future developments in dosage and administrative techniques for terlipressin may have an important role to play in maintaining clinical efficacy whilst improving tolerability in the management of HRS."( Hepatorenal syndrome: the clinical impact of vasoactive therapy.
Colle, I; Laterre, PF, 2018
)
0.72
" Conclusions: The available evidence supports the notion that early combination therapy involving NE and TP holds promise in terms of reducing the required dosage of NE, enhancing renal perfusion, and improving microcirculation in patients diagnosed with septic shock."( TERLIPRESSIN COMBINED WITH NOREPINEPHRINE IN THE TREATMENT OF SEPTIC SHOCK: A SYSTEMATIC REVIEW.
Liang, D; Lin, L; Mao, F; Tang, Z; Xu, Y, 2023
)
2.35
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
polypeptideA peptide containing ten or more amino acid residues.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (2)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
GLS proteinHomo sapiens (human)Potency28.18380.35487.935539.8107AID624170
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency12.58930.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (7)

Assay IDTitleYearJournalArticle
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (750)

TimeframeStudies, This Drug (%)All Drugs %
pre-199044 (5.87)18.7374
1990's99 (13.20)18.2507
2000's235 (31.33)29.6817
2010's264 (35.20)24.3611
2020's108 (14.40)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 79.73

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index79.73 (24.57)
Research Supply Index6.89 (2.92)
Research Growth Index4.97 (4.65)
Search Engine Demand Index142.11 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (79.73)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials161 (19.73%)5.53%
Reviews204 (25.00%)6.00%
Case Studies129 (15.81%)4.05%
Observational7 (0.86%)0.25%
Other315 (38.60%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (86)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT02489864]Phase 430 participants (Anticipated)Interventional2015-07-31Recruiting
A Randomized, Controlled Trial of Ligation Plus Vasoconstrictor vs.Ligation Plus Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding [NCT01112852]Phase 4118 participants (Actual)Interventional2006-12-31Completed
Terlipressin Versus Somatostatin/Octreotide on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage (TORCH): A Retrospective Multicenter Observational Study [NCT03846180]1,682 participants (Actual)Observational2019-03-01Completed
A Prospective, Randomized Controlled Trial of 2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Prevention of Very Early Rebleeding in Patients With Acute Gastroesophageal Variceal Hemorrhage [NCT04056806]Phase 4100 participants (Anticipated)Interventional2019-08-31Recruiting
Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis [NCT03107091]Phase 26 participants (Actual)Interventional2017-07-15Completed
The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial [NCT05170230]54 participants (Anticipated)Interventional2022-02-27Recruiting
Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney [NCT02059460]Phase 425 participants (Actual)Interventional2013-05-31Completed
Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study. [NCT03608514]Phase 2/Phase 3100 participants (Anticipated)Interventional2018-07-01Recruiting
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs [NCT03572088]Phase 240 participants (Actual)Interventional2016-05-31Completed
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty [NCT05774067]135 participants (Actual)Interventional2022-12-01Completed
A Multi-Center, Open Label, Collaborative Research Study to Treat HRS-AKI Patients With Continuous Terlipressin Infusion [NCT04460560]Phase 350 participants (Anticipated)Interventional2020-12-11Active, not recruiting
Hemodynamic Effects of Terlipressin and High Dose Octreotide on Patients With Liver Cirrhosis Related Esophageal Varices: A Randomized, Placebo-controlled Multicenter Trial [NCT02119884]Phase 488 participants (Actual)Interventional2014-02-28Completed
Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock [NCT04948372]22 participants (Actual)Interventional2019-09-01Completed
Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding [NCT02311608]1,320 participants (Anticipated)Observational2014-02-28Recruiting
An Exploratory Study of FE999908 in Patients With Hepatorenal Syndrome Type 1 [NCT01373606]Phase 1/Phase 28 participants (Actual)Interventional2007-11-30Completed
Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study [NCT03336814]Phase 440 participants (Anticipated)Interventional2018-07-27Recruiting
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices [NCT01335516]20 participants (Actual)Observational2010-11-30Completed
A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome - Acute Kidney Injury [NCT05875948]Phase 295 participants (Anticipated)Interventional2023-06-30Recruiting
Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome (HRS): An Open Multicentric Randomized Study [NCT00742339]Phase 2/Phase 349 participants (Actual)Interventional2005-05-31Terminated(stopped due to Decision of independent monitoring committee: Risk of non-response to treatment significantly higher in midodrine group than in terlipressin group.)
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection. [NCT02588716]Phase 284 participants (Actual)Interventional2015-09-30Completed
Randomized Clinical Trial Comparing Noradrenaline Plus Placebo Versus Terlipressin Plus Noradrenaline for the Treatment of Septic Shock [NCT05207280]Phase 3152 participants (Anticipated)Interventional2022-10-11Recruiting
Comparison of The Effectiveness of Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1 [NCT03822091]Phase 360 participants (Actual)Interventional2019-01-28Completed
Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock: A Randomized Controlled Trial [NCT04819568]310 participants (Anticipated)Interventional2021-06-25Recruiting
A Phase 2 Randomized, Dose-Titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 Compared to Standard of Care to Reduce Ascites and Complications in Cirrhotic Patients With Refractory Ascites [NCT04112199]Phase 215 participants (Actual)Interventional2021-06-17Terminated(stopped due to For reasons unrelated to safety or efficacy)
Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study [NCT06108362]Phase 4104 participants (Anticipated)Interventional2023-08-18Recruiting
Efficacy of Continuous Terlipressin Therapy After Endoscopic Variceal Ligation in Acute Variceal Haemorrhage: A Randomised Control Clinical Trial [NCT06027970]Phase 3165 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II [NCT00793559]Phase 230 participants (Anticipated)Interventional2008-11-30Not yet recruiting
Study on the Effect of Terlipressin on Recovery of Liver Function After Hepatectomy: a Multicenter Randomized Controlled Study [NCT04221672]Phase 386 participants (Anticipated)Interventional2019-11-07Recruiting
A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study) [NCT02770716]Phase 3300 participants (Actual)Interventional2016-07-13Completed
A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study) [NCT01143246]Phase 3196 participants (Actual)Interventional2010-10-11Completed
To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding: A Randomized Comparison [NCT02695862]110 participants (Actual)Interventional2016-05-05Completed
[NCT00863837]Phase 4120 participants (Anticipated)Interventional2006-12-31Enrolling by invitation
Terlipressin Given As I.V. Boluses Vs Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome (Hrs): Preliminary Results Of A Randomized Controlled Clinical Study. [NCT00742690]Phase 2/Phase 370 participants (Anticipated)Interventional2005-05-31Recruiting
''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure' [NCT02573727]120 participants (Actual)Interventional2015-10-31Completed
Short-course Somatostatin Versus Terlipressin Infusion in Combination With Endoscopic Variceal Ligation for the Prevention of Early Esophageal Variceal Rebleeding [NCT02757703]Phase 4150 participants (Actual)Interventional2010-05-31Completed
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial. [NCT04961528]Phase 3315 participants (Anticipated)Interventional2022-03-27Recruiting
A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis [NCT05490888]Phase 137 participants (Anticipated)Interventional2022-01-03Recruiting
The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial [NCT05154279]54 participants (Anticipated)Interventional2022-02-27Recruiting
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate [NCT04110418]Phase 236 participants (Anticipated)Interventional2019-02-19Recruiting
Efficacy of Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin. A Multi-center Randomized Controlled Study [NCT00986817]Phase 382 participants (Actual)Interventional2009-11-30Completed
Terlipressin and Albumin in Patients With Type-1 Hepatorenal Syndrome Associated With Sepsis [NCT01932151]18 participants (Actual)Interventional2012-12-31Completed
RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide [NCT00966355]Phase 41,034 participants (Actual)Interventional2006-09-30Completed
A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome [NCT01649037]0 participants (Actual)Interventional2012-08-31Withdrawn(stopped due to lack of funds)
Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery [NCT02718599]Phase 250 participants (Actual)Interventional2016-04-30Completed
Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation [NCT00995839]Phase 2/Phase 360 participants (Actual)Interventional2008-11-30Completed
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase - A Randomized Controlled Study [NCT02788240]14 participants (Actual)Interventional2016-05-01Terminated
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial [NCT05242783]162 participants (Anticipated)Interventional2022-02-01Recruiting
Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices [NCT00534677]Phase 4320 participants (Actual)Interventional2004-05-31Completed
Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903): A Multicenter, Single-blind, Randomised Controlled Trial [NCT04028323]Phase 460 participants (Anticipated)Interventional2019-07-16Recruiting
Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy for the Control of Acute Variceal Bleeding in Patients With Liver Cirrhosis at a Tertiary Center in Mexico [NCT05331768]109 participants (Actual)Interventional2021-01-01Completed
Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial [NCT00628160]Phase 2/Phase 372 participants (Actual)Interventional2006-10-31Completed
"Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. THE TERLIVAP STUDY" [NCT00481572]Phase 245 participants (Actual)Interventional2007-01-31Completed
Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy [NCT02970175]Phase 3130 participants (Anticipated)Interventional2017-06-30Recruiting
Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial [NCT03584087]Phase 474 participants (Actual)Interventional2018-05-07Completed
Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure- A Randomized Open Label Study. [NCT04416282]70 participants (Actual)Interventional2020-06-22Completed
Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS) [NCT01271114]Phase 321 participants (Actual)Interventional2012-06-30Terminated(stopped due to Low recruitment rate)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1 [NCT00089570]Phase 3112 participants (Actual)Interventional2004-06-30Completed
[NCT00115947]Phase 2/Phase 30 participants Interventional2004-12-31Completed
The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding [NCT04358016]Phase 454 participants (Actual)Interventional2018-01-01Completed
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response [NCT01530711]Phase 440 participants (Anticipated)Interventional2012-04-30Active, not recruiting
Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial. [NCT05315557]100 participants (Anticipated)Interventional2022-04-05Not yet recruiting
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed [NCT00369694]Phase 4130 participants (Actual)Interventional2006-08-31Completed
Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study [NCT00287664]Phase 4100 participants Interventional2002-02-28Suspended(stopped due to because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.)
NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY [NCT01637454]Phase 346 participants (Actual)Interventional2009-01-31Completed
A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock [NCT01697410]1,000 participants (Anticipated)Interventional2013-01-31Recruiting
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial. [NCT04353193]Phase 436 participants (Anticipated)Interventional2020-06-30Not yet recruiting
Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial [NCT01921985]Phase 2150 participants (Actual)Interventional2013-11-30Terminated(stopped due to Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation)
What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin [NCT03038503]Phase 360 participants (Anticipated)Interventional2016-12-31Recruiting
Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial [NCT03130127]40 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation [NCT03395574]Phase 230 participants (Actual)Interventional2018-01-25Completed
Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study [NCT00370253]Phase 320 participants (Actual)Interventional2006-09-30Completed
Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled Trial [NCT05346393]124 participants (Anticipated)Interventional2022-11-29Recruiting
An Exploratory Study to Investigate the Haemodynamic Effects of Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension [NCT01640964]Phase 247 participants (Actual)Interventional2013-04-30Completed
Terlipressin Versus Placebo for Septic Shock Refractory to High Doses Catecholamine Vasopressors: A Randomized-controlled Trial [NCT04339868]Phase 2130 participants (Anticipated)Interventional2020-04-03Recruiting
A Prospective Study to Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock [NCT02468063]184 participants (Actual)Interventional2015-05-01Completed
Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis [NCT03144713]150 participants (Actual)Interventional2017-05-28Completed
Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial) [NCT02368249]Phase 20 participants (Actual)Interventional2020-01-31Withdrawn(stopped due to no focus on this topic)
Recruitment of Microcirculation Using Albumin 20% and Terlipressin in Patients With Septic Shock: a Randomized Controlled Double-blinded Study. [NCT05080543]Phase 136 participants (Anticipated)Interventional2021-10-31Not yet recruiting
A Prospective Open Label Randomized Non Inferiority Trial to Compare the Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit. [NCT01836224]84 participants (Actual)Interventional2012-10-31Completed
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets. [NCT05266534]162 participants (Anticipated)Interventional2021-12-30Recruiting
Terlipressin Bolus Versus Continuous Infusion in Patients With Variceal Hemorrhage [NCT04028505]Phase 3128 participants (Anticipated)Interventional2018-10-25Recruiting
Evaluation of the Natural History of Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease [NCT06161766]300 participants (Anticipated)Observational2024-01-15Not yet recruiting
Effects of Terlipressin on Management of Potential Organ Donors:a Retrospective Study [NCT03477461]18 participants (Actual)Observational2015-01-01Completed
the Surgical Intensive Care Unit [NCT02306239]40 participants (Anticipated)Interventional2014-12-31Recruiting
Effect of Terlipressinum on the Portal Vein Pressure of Patients With Liver Tumor After Liver Resection [NCT03352349]Phase 230 participants (Anticipated)Interventional2017-12-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00966355 (2) [back to overview]5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
NCT00966355 (2) [back to overview]Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects
NCT01143246 (5) [back to overview]Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal
NCT01143246 (5) [back to overview]Percentage of Participants With HRS Reversal
NCT01143246 (5) [back to overview]Percentage of Participants With Overall Survival
NCT01143246 (5) [back to overview]Percentage of Participants With Serious Adverse Events
NCT01143246 (5) [back to overview]Percentage of Participants With Transplant-free Survival
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))
NCT01640964 (9) [back to overview]Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)
NCT01640964 (9) [back to overview]Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))
NCT01640964 (9) [back to overview]Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))
NCT01640964 (9) [back to overview]Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin
NCT02726620 (43) [back to overview]30-day Mortality
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Epinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
NCT02726620 (43) [back to overview]Estimated Intraoperative Blood Loss
NCT02726620 (43) [back to overview]In-hospital Mortality
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Intraoperative Administration of Intravenous Fluids
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Postoperative Rise in Creatinine Levels
NCT02726620 (43) [back to overview]Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 50 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 55 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 60 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephinephrine
NCT02770716 (6) [back to overview]Percentage pf Participants in the SIRS Subgroup With HRS Reversal
NCT02770716 (6) [back to overview]Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30
NCT02770716 (6) [back to overview]Percentage of Participants With Verified HRS Reversal
NCT02770716 (6) [back to overview]Percentage of Participants With HRS Reversal
NCT02770716 (6) [back to overview]Percentage of Participants With Durable HRS Reversal
NCT02770716 (6) [back to overview]Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis
NCT03107091 (3) [back to overview]Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
NCT03107091 (3) [back to overview]Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
NCT03107091 (3) [back to overview]Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin

5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)

(NCT00966355)
Timeframe: 5 days after enrollment

Interventionparticipants (Number)
Octreotide218
Somatostatin216
Terlipressin225

[back to top]

Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects

at least one of the three criteria (NCT00966355)
Timeframe: 5 days after enrollment

Interventionparticipants (Number)
Octreotide113
Somatostatin115
Terlipressin114

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Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal

Confirmed HRS Reversal: The percentage of participants with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening renal replacement therapy or liver transplant. (NCT01143246)
Timeframe: within 14 days

Interventionpercentage of participants (Number)
Terlipressin19.6
Placebo13.1

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Percentage of Participants With HRS Reversal

HRS reversal is defined as at least one SCr value of ≤ 1.5 mg/dL on treatment (up to 24 hours after the last dose of study medication). (NCT01143246)
Timeframe: within 14 days

Interventionpercentage of participants (Number)
Terlipressin23.7
Placebo15.2

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Percentage of Participants With Overall Survival

Overall Survival up to 90 days, defined as the time (in days) that each participant survives from the day of randomization. (NCT01143246)
Timeframe: Up to 90 days

Interventionpercentage of participants (Number)
Terlipressin57.7
Placebo54.5

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Percentage of Participants With Serious Adverse Events

Clinically significant changes in vital signs, height, weight, immunogenicity and laboratory assessments which qualified for the definition of serious adverse event are reported. (NCT01143246)
Timeframe: Up to 30 days post treatment (within 44 days)

Interventionpercentage of participants (Number)
Terlipressin66.7
Placebo62.1

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Percentage of Participants With Transplant-free Survival

Transplant-Free Survival up to 90 days, defined as the time (in days) that each participant survives without liver transplantation from the day of randomization. (NCT01143246)
Timeframe: Up to 90 days

Interventionpercentage of participants (Number)
Terlipressin30.9
Placebo26.3

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Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))

"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)." (NCT01640964)
Timeframe: Baseline, 120 min post-infusion

InterventionL/min (Mean)
Part A: Serelaxin (RLX030)0.293

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Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)

Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion). (NCT01640964)
Timeframe: Baseline, 120 min post infusion

InterventionmmHg (Mean)
Part B: Serelaxin (RLX030)-3.7

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Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)

"Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP).~Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion)." (NCT01640964)
Timeframe: Baseline, 120 min post-infusion start

InterventionmmHg (Mean)
Part B: Serelaxin (RLX030)-1.2

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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))

The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment) (NCT01640964)
Timeframe: Baseline, 120 min post infusion

InterventionL/min (Mean)
Part A: Terlipressin Acetate0.059

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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))

The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment) (NCT01640964)
Timeframe: Baseline, 120 min post serelaxin infusion

InterventionL/min (Mean)
Part A: Serelaxin (RLX030)0.438

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Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))

"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)." (NCT01640964)
Timeframe: Baseline, 120 min post-infusion

InterventionL/min (Mean)
Part A: Serelaxin (RLX030)0.002

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Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))

"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)." (NCT01640964)
Timeframe: Baseline, 120 min post-infusion

InterventionL/min (Mean)
Part A: Serelaxin (RLX030)-0.091

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Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))

"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)." (NCT01640964)
Timeframe: Baseline, 120 min post-infusion

InterventionL/min (Mean)
Part A: Serelaxin (RLX030)0.084

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Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin

This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study. (NCT01640964)
Timeframe: 4 weeks

,
InterventionPatients (Number)
Any adverse eventSerious Adverse EventsDeath
Part A: Serelaxin (RLX030)310
Part B: Serelaxin (RLX030)320

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30-day Mortality

Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) (NCT02726620)
Timeframe: 30 days after surgery

InterventionParticipants (Count of Participants)
Usual Care Group511
Hypotension Decision Support143

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Average Use of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group20
Hypotension Decision Support15

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Average Use of Cardiovascular Drugs: Epinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group1.00
Hypotension Decision Support0.70

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Average Use of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.40
Hypotension Decision Support0.40

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Average Use of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.62
Hypotension Decision Support0.70

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Average Use of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.90
Hypotension Decision Support1.30

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group19
Hypotension Decision Support19

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group23
Hypotension Decision Support23

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group57
Hypotension Decision Support52

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group96
Hypotension Decision Support86

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group273
Hypotension Decision Support235

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group485
Hypotension Decision Support417

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Estimated Intraoperative Blood Loss

The estimated blood loss in mL during the surgical procedure (NCT02726620)
Timeframe: During the surgical procedure: an expected average of 2 hours

InterventionmL (Median)
Usual Care Group100
Hypotension Decision Support75

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In-hospital Mortality

Hospital mortality rate during a single hospital admission after the surgery (NCT02726620)
Timeframe: All postoperative days during a single hospital admission, expected median of 5 days

InterventionParticipants (Count of Participants)
Usual Care Group487
Hypotension Decision Support137

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Incidence of a MAP < 50 mmHg

Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group7781
Hypotension Decision Support2196

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Incidence of a MAP < 50 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1159
Hypotension Decision Support326

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Incidence of a MAP < 50 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group304
Hypotension Decision Support85

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Incidence of a MAP < 55 mmHg

Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group10991
Hypotension Decision Support3045

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Incidence of a MAP < 55 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3181
Hypotension Decision Support759

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Incidence of a MAP < 55 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1223
Hypotension Decision Support284

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Incidence of a MAP < 60 mmHg

Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group13779
Hypotension Decision Support3798

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Incidence of a MAP < 60 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group6989
Hypotension Decision Support1723

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Incidence of a MAP < 60 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3632
Hypotension Decision Support792

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Intraoperative Administration of Intravenous Fluids

Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmL (Median)
Usual Care Group1500.00
Hypotension Decision Support1400.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group65.00
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group63.95
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group61.07
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group60.10
Hypotension Decision Support48.59

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Postoperative Rise in Creatinine Levels

Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. (NCT02726620)
Timeframe: Within 7 days after surgery

Interventionmg/dL (Median)
Usual Care Group0.00
Hypotension Decision Support0.00

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Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)

The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes). (NCT02726620)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours

Interventionminutes (Median)
Usual Care Group67
Hypotension Decision Support60

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Timing of Cardiovascular Drugs for MAP < 50 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0

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Timing of Cardiovascular Drugs for MAP < 55 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0.5

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Timing of Cardiovascular Drugs for MAP < 60 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group0.8
Hypotension Decision Support1.5

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Timing of Cardiovascular Drugs for MAP < 65 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group2
Hypotension Decision Support1.14

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Usage Frequency of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group9310
Hypotension Decision Support2718

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Usage Frequency of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group11093
Hypotension Decision Support1257

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Usage Frequency of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group762
Hypotension Decision Support233

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Usage Frequency of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group12211
Hypotension Decision Support3685

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.230.654.70
Usual Care Group1.320.654.28

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.674.65
Usual Care Group1.340.684.60

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.672.33
Usual Care Group1.350.684.36

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.270.682.31
Usual Care Group1.350.684.10

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Usage Frequency of Cardiovascular Drugs: Ephinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1215
Hypotension Decision Support409

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Percentage pf Participants in the SIRS Subgroup With HRS Reversal

Defined as the percentage of participants in the SIRS subgroup with HRS reversal by Day 14 or discharge (NCT02770716)
Timeframe: within 14 days

Interventionpercentage of participants (Number)
Terlipressin33.3
Placebo6.3

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Percentage of Participants With Verified HRS Reversal Without HRS Recurrence by Day 30

Defined as the percentage of participants who had achieved verified HRS reversal by Day 15 or discharge and did not revert to baseline measures by day 30 (NCT02770716)
Timeframe: Day 30

Interventionpercentage of participants (Number)
Terlipressin24.1
Placebo15.8

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Percentage of Participants With Verified HRS Reversal

Defined as the percentage of participants with 2 consecutive SCr values ≤ 1.5 mg/dL at least 2 hours apart, while on treatment by Day 14 or discharge (on treatment defined as up to 24 hours after the final dose of study drug), per protocol. (NCT02770716)
Timeframe: within 15 Days

Interventionpercentage of participants (Number)
Terlipressin29.1
Placebo15.8

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Percentage of Participants With HRS Reversal

Defined as the percentage of participants with a SCr value no more than 1.5 mg/dL by Day 14 or discharge, and were viable (per protocol) for inclusion in the secondary endpoint analysis (NCT02770716)
Timeframe: within 14 days

Interventionpercentage of participants (Number)
Terlipressin36.2
Placebo16.8

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Percentage of Participants With Durable HRS Reversal

Defined as the percentage of participants maintaining HRS reversal without RRT to Day 30 (NCT02770716)
Timeframe: Day 30

Interventionpercentage of participants (Number)
Terlipressin31.7
Placebo15.8

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Percentage of Participants Who Were Viable (Per Protocol) for Inclusion in the Primary End Point Analysis

Defined as the percentage of participants with verified HRS reversal who lived at least 10 days without RRT, and were otherwise viable (per protocol) for inclusion in the primary endpoint analysis (NCT02770716)
Timeframe: within 25 days

Interventionpercentage of participants (Number)
Terlipressin91.3
Placebo94.4

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Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites

Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css) (NCT03107091)
Timeframe: 7 day treatment

Interventionng/mL (Mean)
Terlipressin8-lysine vasopressin
Terlipressin Acetate Continuous Infusion2.480.089

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Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites

Rate of treatment emergent adverse events assessed by physical examination and laboratory safety (NCT03107091)
Timeframe: 28 day treatment period and 28 day post-treatment

InterventionParticipants (Count of Participants)
TEAESerious AERelated TEAESerious related TEAETEAE leading to drug withdrawalGrade 3 TEAEFatal TEAE
Terlipressin Acetate Continuous Infusion6430340

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Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin

Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed (NCT03107091)
Timeframe: 28 day post-treatment

Interventionpercent change (Mean)
Percent change in volume ascites removed during 28d treatment period versus 28d pre-treatment periodPercent change in LVP interval during treatment versus before treatment
Terlipressin Acetate Continuous Infusion-66.5128

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