milrinone and Symptom Cluster studies

Research Excerpts

Excerpt	Relevance	Reference
"To compare levosimendan with milrinone to prevent low cardiac output syndrome in patients undergoing tetralogy of Fallot correction."	9.51	[Levosimendan for preventing low output syndrome in pediatric patients with correction of tetralogy of Fallot]. ( Dosta-Herrera, JJ; Gutiérrez-Riveroll, KI; Mejía Picazo, HJ, 2022)
"There is insufficient evidence of the effectiveness of prophylactic milrinone in preventing death or low cardiac output syndrome in children undergoing surgery for congenital heart disease, compared to placebo."	8.91	Prophylactic milrinone for the prevention of low cardiac output syndrome and mortality in children undergoing surgery for congenital heart disease. ( Burkhardt, BE; Rücker, G; Stiller, B, 2015)
" For these purposes, we reviewed data available from randomized controlled trials on short-term, intermittent, and long-term use of intravenous inodilator agents (dobutamine, dopamine, and milrinone) in AHFS."	6.43	Reassessment of dobutamine, dopamine, and milrinone in the management of acute heart failure syndromes. ( Bayram, M; De Luca, L; Gheorghiade, M; Massie, MB, 2005)
"To compare levosimendan with milrinone to prevent low cardiac output syndrome in patients undergoing tetralogy of Fallot correction."	5.51	[Levosimendan for preventing low output syndrome in pediatric patients with correction of tetralogy of Fallot]. ( Dosta-Herrera, JJ; Gutiérrez-Riveroll, KI; Mejía Picazo, HJ, 2022)
"There is insufficient evidence of the effectiveness of prophylactic milrinone in preventing death or low cardiac output syndrome in children undergoing surgery for congenital heart disease, compared to placebo."	4.91	Prophylactic milrinone for the prevention of low cardiac output syndrome and mortality in children undergoing surgery for congenital heart disease. ( Burkhardt, BE; Rücker, G; Stiller, B, 2015)
"Population pharmacokinetic modeling and simulations suggest a slow loading dose followed by maintenance infusion to reach therapeutic milrinone plasma concentrations within the timeframe of the postligation cardiac syndrome."	3.91	Population Pharmacokinetics and Dosing of Milrinone After Patent Ductus Arteriosus Ligation in Preterm Infants. ( Hallik, M; Ilmoja, ML; Jalas, T; Kipper, K; Metsvaht, T; Raidmäe, M; Standing, JF; Starkopf, J; Takkis, K; Tasa, T; Uibo, K; Veigure, R, 2019)
" For these purposes, we reviewed data available from randomized controlled trials on short-term, intermittent, and long-term use of intravenous inodilator agents (dobutamine, dopamine, and milrinone) in AHFS."	2.43	Reassessment of dobutamine, dopamine, and milrinone in the management of acute heart failure syndromes. ( Bayram, M; De Luca, L; Gheorghiade, M; Massie, MB, 2005)

Research

Studies (8)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Number of Participants With a Post-operative Length of Stay Greater Than 90 Days

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	5 (62.50)	29.6817
2010's	2 (25.00)	24.3611
2020's	1 (12.50)	2.80

Authors	Studies
Gutiérrez-Riveroll, KI	1
Mejía Picazo, HJ	1
Dosta-Herrera, JJ	1
Hallik, M	1
Ilmoja, ML	1
Tasa, T	1
Standing, JF	1
Takkis, K	1
Veigure, R	1
Kipper, K	1
Jalas, T	1
Raidmäe, M	1
Uibo, K	1
Starkopf, J	1
Metsvaht, T	1
Burkhardt, BE	1
Rücker, G	1
Stiller, B	1
Bouchard, M	1
Verreault, S	1
Gariépy, JL	1
Dupré, N	1
Donlan, SM	1
Quattromani, E	1
Pang, PS	1
Gheorghiade, M	2
Hoffman, TM	2
Wernovsky, G	2
Atz, AM	2
Kulik, TJ	2
Nelson, DP	2
Chang, AC	2
Bailey, JM	2
Akbary, A	2
Kocsis, JF	2
Kaczmarek, R	1
Spray, TL	2
Wessel, DL	2
Bayram, M	1
De Luca, L	1
Massie, MB	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)[NCT03229538]	Phase 3	1,263 participants (Actual)	Interventional	2017-10-18	Completed
Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.[NCT00549107]	Phase 2	40 participants (Anticipated)	Interventional	2007-09-30	Recruiting
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass[NCT00934843]		77 participants (Actual)	Interventional	2007-03-31	Completed
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation[NCT02519335]	Phase 1	12 participants (Actual)	Interventional	2014-09-30	Terminated (stopped due to PI no longer at this facility)
2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB[NCT00819377]	Phase 2	124 participants (Anticipated)	Interventional	2009-02-28	Completed
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery[NCT04997291]	Phase 1	12 participants (Anticipated)	Interventional	2021-04-09	Recruiting
Perioperative Use of Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass[NCT05063370]	Phase 2	40 participants (Actual)	Interventional	2021-08-18	Active, not recruiting
Platelet and Tissue cAMP: Novel Biomarkers of Milrinone Efficacy in Children[NCT02728128]		53 participants (Actual)	Observational	2016-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Calculated as discharge date minus surgery date. (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.

Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	18
Placebo Arm	29

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	237
Placebo Arm	264

The 7 highest global ranking categories range from 91 (postoperative length of hospital stay > 90 days) to 97 (operative mortality). (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.

Number of Participants With Post-operative Low Cardiac Output Syndrome

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	103
Placebo Arm	122

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	12
Placebo Arm	17

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	31
Placebo Arm	24

"Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable." (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)

Inotropic Score

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	31
Placebo Arm	37

Intervention	Participants (Count of Participants)
Methylprednisolone Arm	41
Placebo Arm	51

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score. (NCT00934843)
Timeframe: over the first 36 hours after surgery

Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

Intervention	Scores on a scale (Mean)
MP Single Dose	14.4
MP Two Dose	15.0

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery (NCT00934843)
Timeframe: at 36 hours and 30 days

Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

Intervention	participants (Number)
MP Single Dose	1
MP Two Dose	0

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support. (NCT00934843)
Timeframe: 36 hours

Urine Output

Intervention	participants (Number)
MP Single Dose	17
MP Two Dose	15

Total urine output in mL over the first 36 hours after cardiac surgery (NCT00934843)
Timeframe: over 36 hours

Total Intake/Output of Fluid

Intervention	mL (Mean)
MP Single Dose	498
MP Two Dose	453

Total amount of all fluids in and out during the first 36 hours postoperatively in mL. (NCT00934843)
Timeframe: over 36 hours

Intervention	mL (Mean)
	Total Fluid in at 36 hr	Total Fluid out at 36 hr
MP Single Dose	575	600
MP Two Dose	586	558

Article	Year
[Levosimendan for preventing low output syndrome in pediatric patients with correction of tetralogy of Fallot]. Revista medica del Instituto Mexicano del Seguro Social, 2022, May-02, Volume: 60, Issue:3 Topics: Cardiac Output, Low; Cardiotonic Agents; Child; Humans; Hydrazones; Longitudinal Studies; Milrinone;	2022
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation, 2003, Feb-25, Volume: 107, Issue:7 Topics: Blood Pressure; Cardiac Output, Low; Child; Child, Preschool; Double-Blind Method; Endpoint Determin	2003
Prophylactic intravenous use of milrinone after cardiac operation in pediatrics (PRIMACORP) study. Prophylactic Intravenous Use of Milrinone After Cardiac Operation in Pediatrics. American heart journal, 2002, Volume: 143, Issue:1 Topics: Cardiac Output, Low; Cardiopulmonary Bypass; Cardiotonic Agents; Child, Preschool; Double-Blind Meth	2002

milrinone and Symptom Cluster