spironolactone has been researched along with Acute Kidney Failure in 44 studies
Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.
Excerpt | Relevance | Reference |
---|---|---|
"In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone." | 9.19 | Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from ( Bakris, G; Dobre, D; Girerd, N; Krum, H; McMurray, JJ; Messig, M; Pitt, B; Rossignol, P; Shi, H; Swedberg, K; van Veldhuisen, DJ; Vincent, J; Zannad, F, 2014) |
"To quantify the risk of hyperkalemia and acute kidney injury (AKI) when spironolactone use is added on to loop diuretic use among patients with heart failure, and to evaluate whether the risk is modified by level of kidney function." | 7.96 | Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure. ( Alexander, GC; Chang, AR; Coresh, J; Grams, ME; Inker, LA; Qiao, Y; Secora, AM; Shin, JI, 2020) |
"Our results show that MR antagonism administered, either immediately or 3 h after I/R, effectively prevented ischemic acute renal injury, indicating that spironolactone is a promising agent for preventing acute kidney injury once an ischemic insult has occurred." | 7.78 | Recovery from ischemic acute kidney injury by spironolactone administration. ( Barrera-Chimal, J; Bobadilla, NA; Cruz, C; Gamba, G; Garzón-Muvdi, J; Pérez-Villalva, R; Rodríguez-Romo, R; Sánchez-Pozos, K, 2012) |
"The renal tubular necrosis and calcification as well as the mortality induced by mercuric chloride in the rat are readily prevented by prior treatment with well-tolerated amounts of spironolactone." | 7.65 | Mercury poisoning: prevention by spironolactone. ( Selye, H, 1970) |
"Treatment with spironolactone either before or after ischemia prevented subsequent CKD by avoiding the activation of fibrotic and inflammatory pathways." | 5.39 | Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. ( Barrera-Chimal, J; Bobadilla, NA; Gamba, G; Pérez-Villalva, R; Reyna, J; Rodríguez-Romo, R; Uribe, N, 2013) |
"In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone." | 5.19 | Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from ( Bakris, G; Dobre, D; Girerd, N; Krum, H; McMurray, JJ; Messig, M; Pitt, B; Rossignol, P; Shi, H; Swedberg, K; van Veldhuisen, DJ; Vincent, J; Zannad, F, 2014) |
" Spironolactone, furosemide, and trimethoprim with sulfamethoxazole are medicines that, in particular, need to be used carefully and monitored closely in patients in the community at risk of acute kidney injury." | 4.12 | Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case-Control Study with a Focus on Medicines Used in Primary Care. ( Kassie, GM; Kerr, M; Moffat, A; Pratt, N; Roughead, EE, 2022) |
"To quantify the risk of hyperkalemia and acute kidney injury (AKI) when spironolactone use is added on to loop diuretic use among patients with heart failure, and to evaluate whether the risk is modified by level of kidney function." | 3.96 | Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure. ( Alexander, GC; Chang, AR; Coresh, J; Grams, ME; Inker, LA; Qiao, Y; Secora, AM; Shin, JI, 2020) |
"Our results show that MR antagonism administered, either immediately or 3 h after I/R, effectively prevented ischemic acute renal injury, indicating that spironolactone is a promising agent for preventing acute kidney injury once an ischemic insult has occurred." | 3.78 | Recovery from ischemic acute kidney injury by spironolactone administration. ( Barrera-Chimal, J; Bobadilla, NA; Cruz, C; Gamba, G; Garzón-Muvdi, J; Pérez-Villalva, R; Rodríguez-Romo, R; Sánchez-Pozos, K, 2012) |
"Despite a marked increased in the use of spironolactone in patients with and without heart failure, no increase was seen in hospital admissions for hyperkalaemia and outpatient hyperkalaemia actually fell." | 3.76 | Spironolactone use and renal toxicity: population based longitudinal analysis. ( Fahey, T; Macdonald, TM; Struthers, AD; Watson, AD; Wei, L, 2010) |
"A 75-year-old man with post-MI heart failure and an ejection fraction of 15 % was treated with an ACE-inhibitor, spironolactone and a beta-blocker." | 3.76 | [An elderly man with known heart failure admitted with cardiogenic shock]. ( Fagerheim, AK; Hardersen, R; Hovland, A; Nielsen, EW, 2010) |
"In 3 patients with severe cardiac failure high dose therapy with the ACE inhibitor enalapril was instituted during a state of extracellular volume depletion." | 3.67 | [Severe complications during enalapril therapy for heart insufficiency]. ( Stäubli, M; Wieland, T, 1988) |
"Acute reversible renal failure with hyperkalemia developed in a 42-year-old woman during treatment of heart failure and hypertension with high doses of enalapril and diuretics." | 3.67 | [Acute reversible kidney insufficiency due to enalapril during diuretic-treated heart insufficiency]. ( Degenhardt, S, 1987) |
"The renal tubular necrosis and calcification as well as the mortality induced by mercuric chloride in the rat are readily prevented by prior treatment with well-tolerated amounts of spironolactone." | 3.65 | Mercury poisoning: prevention by spironolactone. ( Selye, H, 1970) |
"However, incidence of postoperative low cardiac output state (p < 0." | 1.48 | Preoperative aldosterone receptor blockade and outcomes of cardiac surgery in patients with chronic kidney disease . ( Bitran, D; Fink, D; Merin, O; Shavit, L; Silberman, S; Tauber, R, 2018) |
"Spironolactone was the predominantly prescribed aldosterone antagonist." | 1.43 | Effectiveness and Safety of Aldosterone Antagonist Therapy Use Among Older Patients With Reduced Ejection Fraction After Acute Myocardial Infarction. ( Das, S; de Lemos, JA; Fonarow, GC; Peng, SA; Peterson, ED; Vora, AN; Wang, TY, 2016) |
" The aim of this study was to assess whether appropriate dosage adjustments were made in hospitalized patients with renal impairment." | 1.42 | Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia. ( Getachew, H; Shibeshi, W; Tadesse, Y, 2015) |
"In patients with congestive heart failure (CHF), use of loop diuretic therapy may result in acute kidney insufficiency (AKI)." | 1.39 | Predisposing factors for acute kidney injury in Hispanic patients treated with diuretics for decompensated heart failure. ( Cangiano, JL; López, JE; Marmorato, R; Pagán, P; Ramírez, T; Ricci, F; Soto-Salgado, M; Vega, J, 2013) |
"Treatment with spironolactone either before or after ischemia prevented subsequent CKD by avoiding the activation of fibrotic and inflammatory pathways." | 1.39 | Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. ( Barrera-Chimal, J; Bobadilla, NA; Gamba, G; Pérez-Villalva, R; Reyna, J; Rodríguez-Romo, R; Uribe, N, 2013) |
"Hypertension is a major risk factor for the development and progression of chronic kidney disease (CKD)." | 1.38 | Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease. ( Acelajado, MC; Calhoun, DA; Cartmill, FR; Cofield, SS; Dell'Italia, LJ; Dudenbostel, T; Oparil, S; Pisoni, R, 2012) |
"NSAID are frequently prescribed in elderly patients treated with ACEI or ARB in combination with diuretics." | 1.35 | Exposure of the elderly to potential nephrotoxic drug combinations in Belgium. ( De Haes, JF; De Swaef, A; Jorens, PG; Smets, HL; Verpooten, GA, 2008) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 11 (25.00) | 18.7374 |
1990's | 1 (2.27) | 18.2507 |
2000's | 2 (4.55) | 29.6817 |
2010's | 27 (61.36) | 24.3611 |
2020's | 3 (6.82) | 2.80 |
Authors | Studies |
---|---|
Roughead, EE | 1 |
Kerr, M | 1 |
Moffat, A | 1 |
Kassie, GM | 1 |
Pratt, N | 1 |
Secora, AM | 1 |
Shin, JI | 1 |
Qiao, Y | 1 |
Alexander, GC | 1 |
Chang, AR | 1 |
Inker, LA | 1 |
Coresh, J | 1 |
Grams, ME | 1 |
Watanabe, K | 1 |
Hamada, T | 1 |
Shimada, K | 1 |
Fujimaru, T | 1 |
Ito, Y | 1 |
Nagahama, M | 1 |
Taki, F | 1 |
Nakayama, M | 1 |
Madero, M | 2 |
Vazquez-Rangel, A | 2 |
Gamba, G | 6 |
Zhang, W | 2 |
Xue, F | 1 |
Chu, HC | 1 |
Shavit, L | 1 |
Silberman, S | 1 |
Tauber, R | 1 |
Merin, O | 1 |
Bitran, D | 1 |
Fink, D | 1 |
Barrera-Chimal, J | 6 |
Rocha, L | 1 |
Amador-Martínez, I | 1 |
Pérez-Villalva, R | 5 |
González, R | 1 |
Cortés-González, C | 2 |
Uribe, N | 2 |
Ramírez, V | 1 |
Berman, N | 1 |
Bobadilla, NA | 6 |
Ojeda-Cervantes, M | 2 |
Alberú, J | 1 |
Morales-Buenrostro, LE | 2 |
Ricci, F | 1 |
Ramírez, T | 1 |
Marmorato, R | 1 |
Vega, J | 1 |
Pagán, P | 1 |
López, JE | 1 |
Soto-Salgado, M | 1 |
Cangiano, JL | 1 |
Chou, YH | 1 |
Lin, SL | 1 |
Rossignol, P | 2 |
Dobre, D | 1 |
McMurray, JJ | 1 |
Swedberg, K | 1 |
Krum, H | 1 |
van Veldhuisen, DJ | 1 |
Shi, H | 1 |
Messig, M | 1 |
Vincent, J | 1 |
Girerd, N | 1 |
Bakris, G | 1 |
Pitt, B | 1 |
Zannad, F | 2 |
Fiuzat, M | 1 |
Burnett, JC | 1 |
Calvier, L | 1 |
Martinez-Martinez, E | 1 |
Miana, M | 1 |
Cachofeiro, V | 1 |
Rousseau, E | 1 |
Sádaba, JR | 1 |
López-Andrés, N | 1 |
Getachew, H | 1 |
Tadesse, Y | 1 |
Shibeshi, W | 1 |
Riegel, W | 1 |
Krüger, B | 1 |
Wang, TY | 1 |
Vora, AN | 1 |
Peng, SA | 1 |
Fonarow, GC | 1 |
Das, S | 1 |
de Lemos, JA | 1 |
Peterson, ED | 1 |
Barba-Navarro, R | 1 |
Tapia-Silva, M | 1 |
Garza-Garcia, C | 1 |
López-Giacoman, S | 1 |
Melgoza-Toral, I | 1 |
Bazúa-Valenti, S | 1 |
Bobadilla, N | 1 |
Wasung de Lay, M | 1 |
Baranda, F | 1 |
Chawla, LS | 1 |
Bar-Nur, D | 1 |
Jaber, BL | 1 |
Smets, HL | 1 |
De Haes, JF | 1 |
De Swaef, A | 1 |
Jorens, PG | 1 |
Verpooten, GA | 1 |
Wei, L | 1 |
Struthers, AD | 1 |
Fahey, T | 1 |
Watson, AD | 1 |
Macdonald, TM | 1 |
Hovland, A | 1 |
Fagerheim, AK | 1 |
Hardersen, R | 1 |
Nielsen, EW | 1 |
Kawarazaki, H | 1 |
Ando, K | 1 |
Fujita, M | 1 |
Matsui, H | 1 |
Nagae, A | 1 |
Muraoka, K | 1 |
Kawarasaki, C | 1 |
Fujita, T | 2 |
Pisoni, R | 1 |
Acelajado, MC | 1 |
Cartmill, FR | 1 |
Dudenbostel, T | 1 |
Dell'Italia, LJ | 1 |
Cofield, SS | 1 |
Oparil, S | 1 |
Calhoun, DA | 1 |
Kawarazaki, W | 1 |
Nagase, M | 1 |
Yoshida, S | 1 |
Takeuchi, M | 1 |
Ishizawa, K | 1 |
Ayuzawa, N | 1 |
Ueda, K | 1 |
Sánchez-Pozos, K | 1 |
Garzón-Muvdi, J | 1 |
Rodríguez-Romo, R | 2 |
Cruz, C | 1 |
Latus, J | 1 |
Braun, N | 1 |
Alscher, MD | 1 |
Kimmel, M | 1 |
Billings, FT | 1 |
Pretorius, M | 1 |
Schildcrout, JS | 1 |
Mercaldo, ND | 1 |
Byrne, JG | 1 |
Ikizler, TA | 1 |
Brown, NJ | 1 |
Reyna, J | 1 |
Zhou, Q | 1 |
Liu, K | 1 |
Wu, H | 1 |
Chen, L | 1 |
Pouranan, V | 1 |
Yuan, M | 1 |
Xiao, Z | 1 |
Peng, W | 1 |
Xiang, A | 1 |
Tang, R | 1 |
Wrenger, E | 1 |
Müller, R | 1 |
Moesenthin, M | 1 |
Welte, T | 1 |
Frölich, JC | 1 |
Neumann, KH | 1 |
Priebe, HJ | 1 |
Hancock, EW | 1 |
Davies, DL | 1 |
Wilson, GM | 1 |
Krumlovsky, FA | 1 |
del Greco, F | 1 |
Wieland, T | 1 |
Stäubli, M | 1 |
Degenhardt, S | 1 |
Bodin, F | 1 |
Liguory, C | 1 |
Capelle, P | 1 |
Conte, M | 1 |
Raynaud, R | 1 |
Brochier, M | 1 |
Raynaud, P | 1 |
Fauchier, JP | 1 |
Frazier, HS | 1 |
Yager, H | 1 |
Căruntu, M | 1 |
Mihail, A | 1 |
Selye, H | 1 |
Lieberman, FL | 1 |
Reynolds, TB | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure[NCT00232180] | Phase 3 | 2,743 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
A Non-interventional, Multicenter, Observational Clinical Trial to Assess Eplerenone Treatment in Patients With Heart Failure.[NCT02344199] | 450 participants (Actual) | Observational | 2015-03-31 | Completed | |||
Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA[NCT01681823] | Phase 2 | 60 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery[NCT02417896] | 150 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting | |||
Usefulness of Spironolactone for the Prevention of Acute Kidney Injury in Critically Ill Patients With Invasive Mechanical Ventilation[NCT03206658] | Phase 3 | 90 participants (Anticipated) | Interventional | 2017-08-01 | Not yet recruiting | ||
RAAS, Inflammation, and Post-operative AF[NCT00141778] | Phase 2/Phase 3 | 455 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) |
---|---|
Eplerenone: Double-blind Phase | 288 |
Placebo: Double-blind Phase | 392 |
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
Intervention | participants (Number) |
---|---|
Eplerenone: Double-blind Phase | 249 |
Placebo: Double-blind Phase | 356 |
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 408 | 463 |
Placebo: Double-blind Phase | 491 | 552 |
Death due to any cause. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 171 | 205 |
Placebo: Double-blind Phase | 213 | 253 |
Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 462 | 530 |
Placebo: Double-blind Phase | 569 | 636 |
Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 270 | 311 |
Placebo: Double-blind Phase | 376 | 418 |
First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 304 | 346 |
Placebo: Double-blind Phase | 399 | 439 |
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 147 | 178 |
Placebo: Double-blind Phase | 185 | 215 |
(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 45 | 49 |
Placebo: Double-blind Phase | 33 | 40 |
(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 21 | 24 |
Placebo: Double-blind Phase | 26 | 31 |
First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 164 | 186 |
Placebo: Double-blind Phase | 253 | 277 |
Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 170 | 194 |
Placebo: Double-blind Phase | 262 | 287 |
First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 4 | 4 |
Placebo: Double-blind Phase | 3 | 3 |
First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 9 | 10 |
Placebo: Double-blind Phase | 8 | 10 |
First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 61 | 76 |
Placebo: Double-blind Phase | 59 | 78 |
First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 1364, 1373) | Up to 59.5 months (complete DB) (n= 1367, 1376) | |
Eplerenone: Double-blind Phase | 33 | 45 |
Placebo: Double-blind Phase | 41 | 53 |
New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 950, 937) | Up to 59.5 months (complete DB) (n= 956, 940) | |
Eplerenone: Double-blind Phase | 32 | 41 |
Placebo: Double-blind Phase | 52 | 59 |
The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Intervention | participants (Number) | |
---|---|---|
Up to 50 months (cut-off) (n= 904, 973) | Up to 59.5 months (complete DB) (n= 907, 975) | |
Eplerenone: Double-blind Phase | 34 | 42 |
Placebo: Double-blind Phase | 40 | 47 |
Percentage of patients with a creatinine concentrations >2.5mg/dl (NCT00141778)
Timeframe: Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.
Intervention | percentage of patients (Number) |
---|---|
Placebo | 5.4 |
Ramipril | 0.7 |
Spironolactone | 0.7 |
The percentage of patients in each study arm who died. (NCT00141778)
Timeframe: Measured until the time of hospital discharge
Intervention | percentage of patients (Number) |
---|---|
Placebo | 1.4 |
Ramipril | 2.0 |
Spironolactone | 0 |
Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L (NCT00141778)
Timeframe: Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.
Intervention | percentage of patients (Number) |
---|---|
Placebo | 11.6 |
Ramipril | 13.8 |
Spironolactone | 6.8 |
Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use. (NCT00141778)
Timeframe: Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.
Intervention | percentage of patients (Number) |
---|---|
Placebo | 5.4 |
Ramipril | 10.6 |
Spironolactone | 10.2 |
(NCT00141778)
Timeframe: Measured from the day of surgery until the time of hospital discharge
Intervention | days (Mean) |
---|---|
Placebo | 6.8 |
Ramipril | 5.7 |
Spironolactone | 5.8 |
The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist. (NCT00141778)
Timeframe: Measured from admission to the ICU until discharge from hospital
Intervention | percentage of patients (Number) |
---|---|
Placebo | 27.2 |
Ramipril | 27.8 |
Spironolactone | 25.9 |
Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT. (NCT00141778)
Timeframe: Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.
Intervention | percentage of patients (Number) |
---|---|
Placebo | 2.7 |
Ramipril | 1.3 |
Spironolactone | 2.0 |
It is the time in minutes that it took to extubate the patient after surgery. (NCT00141778)
Timeframe: It is the time (in minutes) from admission to the ICU until tracheal extubation
Intervention | minutes (Mean) |
---|---|
Placebo | 1091.3 |
Ramipril | 970.1 |
Spironolactone | 576.4 |
C-reactive protein was measured at several time points (see table) over the course of the study. (NCT00141778)
Timeframe: Perioperative period
Intervention | ug/mL (Mean) | ||||
---|---|---|---|---|---|
Initiation of surgery | Postoperative day 1 | Postoperative day 2 | Postoperative day 3 | Postoperative day 4 | |
Placebo | 4.1 | 51.4 | 134.8 | 128.3 | 94.1 |
Ramipril | 4.3 | 49.9 | 131.0 | 164.8 | 105.2 |
Spironolactone | 3.9 | 64.3 | 127.8 | 189.4 | 126.5 |
Interleukin-6 was measured at several time points (see time points in table) over the course of the study (NCT00141778)
Timeframe: Perioperative period
Intervention | pg/ml (Mean) | |||||
---|---|---|---|---|---|---|
Initiation of surgery | 30min intraop | 60min intraop | Postop | Postoperative day 1 | Postoperative day 2 | |
Placebo | 4.7 | 12.0 | 15.6 | 130.0 | 119.0 | 100.3 |
Ramipril | 4.6 | 20.5 | 28.8 | 202.1 | 171.0 | 95.5 |
Spironolactone | 6.6 | 11.3 | 17.4 | 145.7 | 164.9 | 109.6 |
Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study. (NCT00141778)
Timeframe: Perioperative period
Intervention | ng/mL (Mean) | |||||
---|---|---|---|---|---|---|
Initiation of surgery | 30min intraop | 60min intraop | Postop | Postoperative day 1 | Postoperative day 2 | |
Placebo | 19.6 | 19.2 | 21.0 | 36.4 | 55.2 | 28.1 |
Ramipril | 16.2 | 19.7 | 22.0 | 38.9 | 47.9 | 25.7 |
Spironolactone | 17.3 | 17.3 | 20.1 | 34.0 | 48.9 | 31.0 |
4 reviews available for spironolactone and Acute Kidney Failure
Article | Year |
---|---|
[Dialysis and renal transplantation: update 2015].
Topics: Acute Kidney Injury; Adrenergic beta-Antagonists; Anticoagulants; Evidence-Based Medicine; Germany; | 2015 |
Diuretics.
Topics: Acetazolamide; Acute Kidney Injury; Chlorothiazide; Diuretics; Diuretics, Osmotic; Ethacrynic Acid; | 1984 |
Diuretics: mechanism of action and clinical application.
Topics: Acute Kidney Injury; Amiloride; Animals; Benzothiadiazines; Diabetes Insipidus; Diuretics; Diuretics | 1975 |
The clinical use of diuretics. 2.
Topics: Acute Kidney Injury; Diabetes Insipidus; Diuretics; Ethacrynic Acid; Furosemide; Humans; Hypertensio | 1973 |
3 trials available for spironolactone and Acute Kidney Failure
37 other studies available for spironolactone and Acute Kidney Failure
Article | Year |
---|---|
Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case-Control Study with a Focus on Medicines Used in Primary Care.
Topics: Acute Kidney Injury; Adverse Drug Reaction Reporting Systems; Amlodipine; Amphotericin B; Australia; | 2022 |
Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure.
Topics: Acute Kidney Injury; Adult; Aged; Diuretics; Female; Follow-Up Studies; Heart Failure; Humans; Hyper | 2020 |
Efficacy of renin-angiotensin-aldosterone system blockades for acute phase hypertensive emergencies in patient complicating severe acute kidney injury.
Topics: Acute Kidney Injury; Adult; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibito | 2022 |
In Reply to 'Assessing the Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery'.
Topics: Acute Kidney Injury; Cardiac Surgical Procedures; Humans; Spironolactone | 2017 |
Assessing the Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery.
Topics: Acute Kidney Injury; Cardiac Surgical Procedures; Humans; Spironolactone | 2017 |
Preoperative aldosterone receptor blockade and outcomes of cardiac surgery in patients with chronic kidney disease
.
Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Cardiac Output, Low; Cardiac Surgical Procedures; Fema | 2018 |
Delayed spironolactone administration prevents the transition from acute kidney injury to chronic kidney disease through improving renal inflammation.
Topics: Acute Kidney Injury; Animals; Delayed-Action Preparations; Disease Models, Animal; Disease Progressi | 2019 |
Predisposing factors for acute kidney injury in Hispanic patients treated with diuretics for decompensated heart failure.
Topics: Acute Kidney Injury; Adult; Aged; Blood Urea Nitrogen; Creatinine; Diabetes Mellitus; Drug Utilizati | 2013 |
The authors reply.
Topics: Acute Kidney Injury; Animals; Ischemia; Male; Renal Insufficiency, Chronic; Spironolactone | 2013 |
How to confirm the specific effect of spironolactone in chronic kidney disease caused by ischemic acute kidney injury?
Topics: Acute Kidney Injury; Animals; Ischemia; Male; Renal Insufficiency, Chronic; Spironolactone | 2013 |
Biomarkers, mineralocorticoid receptor antagonism, and cardiorenal remodeling.
Topics: Acute Kidney Injury; Animals; Galectin 3; Heart Failure; Interleukins; Male; Myocardial Infarction; | 2015 |
The impact of galectin-3 inhibition on aldosterone-induced cardiac and renal injuries.
Topics: Acute Kidney Injury; Aldosterone; Animals; Disease Models, Animal; Enzyme-Linked Immunosorbent Assay | 2015 |
Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia.
Topics: Acute Kidney Injury; Adolescent; Adult; Aged; Aged, 80 and over; Allopurinol; Anti-Arrhythmia Agents | 2015 |
Effectiveness and Safety of Aldosterone Antagonist Therapy Use Among Older Patients With Reduced Ejection Fraction After Acute Myocardial Infarction.
Topics: Acute Kidney Injury; Age Factors; Aged; Aged, 80 and over; Databases, Factual; Drug Prescriptions; D | 2016 |
Mineralocorticoid Receptor Blockade for Prevention of Acute Kidney Injury: An Elusive Target.
Topics: Acute Kidney Injury; Aldosterone; Humans; Kidney; Mineralocorticoid Receptor Antagonists; Receptors, | 2017 |
Exposure of the elderly to potential nephrotoxic drug combinations in Belgium.
Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-C | 2008 |
Spironolactone use and renal toxicity: population based longitudinal analysis.
Topics: Acute Kidney Injury; Aged; Angiotensin-Converting Enzyme Inhibitors; Creatine; Female; Heart Failure | 2010 |
[An elderly man with known heart failure admitted with cardiogenic shock].
Topics: Acute Kidney Injury; Adrenergic beta-Antagonists; Aged; Angiotensin II Type 1 Receptor Blockers; Ang | 2010 |
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular | 2011 |
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular | 2011 |
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular | 2011 |
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular | 2011 |
Mineralocorticoid receptor activation: a major contributor to salt-induced renal injury and hypertension in young rats.
Topics: Acute Kidney Injury; Aldosterone; Analysis of Variance; Angiotensin II Type 1 Receptor Blockers; Ani | 2011 |
Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease.
Topics: Acute Kidney Injury; Aged; Alabama; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting | 2012 |
Angiotensin II- and salt-induced kidney injury through Rac1-mediated mineralocorticoid receptor activation.
Topics: Acute Kidney Injury; Adrenalectomy; Aldosterone; Analysis of Variance; Angiotensin II; Animals; Blot | 2012 |
Recovery from ischemic acute kidney injury by spironolactone administration.
Topics: Acute Kidney Injury; Aldosterone; Animals; Drug Administration Schedule; HSP72 Heat-Shock Proteins; | 2012 |
Life-threatening hyperkalemia--an overlooked acute kidney injury with a serum creatinine rise in the 'normal' range.
Topics: Acute Kidney Injury; Aged; Creatinine; Diuretics; Electrocardiography; Female; Humans; Hyperkalemia; | 2012 |
Obesity and oxidative stress predict AKI after cardiac surgery.
Topics: Acute Kidney Injury; Aged; Angiotensin-Converting Enzyme Inhibitors; Biomarkers; Body Mass Index; Ca | 2012 |
Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury.
Topics: Acute Kidney Injury; Animals; Collagen Type I; Disease Models, Animal; Diuretics; Dose-Response Rela | 2013 |
Spironolactone rescues Dot1a-Af9-mediated repression of endothelin-1 and improves kidney injury in streptozotocin-induced diabetic rats.
Topics: Acute Kidney Injury; Aldosterone; Animals; Diabetes Mellitus, Experimental; Diabetic Nephropathies; | 2012 |
Interaction of spironolactone with ACE inhibitors or angiotensin receptor blockers: analysis of 44 cases.
Topics: Acute Kidney Injury; Aged; Angiotensin Receptor Antagonists; Antihypertensive Agents; Diuretics; Dru | 2003 |
Normal ECG or peaked T waves?
Topics: Acute Kidney Injury; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Diabetes Mell | 1998 |
Diuretic agents. Mechanisms of action and clinical uses.
Topics: Acute Kidney Injury; Benzothiadiazines; Carbonic Anhydrase Inhibitors; Diabetes Insipidus; Diuretics | 1976 |
[Severe complications during enalapril therapy for heart insufficiency].
Topics: Acute Kidney Injury; Drug Interactions; Enalapril; Heart Failure; Humans; Hypotension; Male; Middle | 1988 |
[Acute reversible kidney insufficiency due to enalapril during diuretic-treated heart insufficiency].
Topics: Acute Kidney Injury; Adult; Drug Therapy, Combination; Enalapril; Female; Heart Failure; Humans; Hyp | 1987 |
[Disorders of water-electrolyte metabolism associated with decompensated cirrhosis. The danger of various therapeutic drugs].
Topics: Acute Kidney Injury; Adult; Aged; Ascites; Blood Transfusion; Blood Urea Nitrogen; Blood Volume Dete | 1968 |
[Hyperkalemias in cardiac patients].
Topics: Acidosis; Acute Kidney Injury; Adult; Aged; Arrhythmias, Cardiac; Digitalis Glycosides; Diuretics; F | 1974 |
[New aspects of the use of spironolactone and its association with thiabutazide (per os and in injections) in the treatment of grave cardiac insufficiency].
Topics: Acute Kidney Injury; Administration, Oral; Adult; Aged; Benzothiadiazines; Diabetes Complications; D | 1974 |
Mercury poisoning: prevention by spironolactone.
Topics: Acute Kidney Injury; Animals; Chelating Agents; Dimercaprol; Female; Kidney Tubules; Mercury Poisoni | 1970 |
Renal failure with cirrhosis. Observations on the role of diuretics.
Topics: Acute Kidney Injury; Aminohippuric Acids; Ascites; Blood; Blood Volume; Creatine; Diuretics; Ethacry | 1966 |