CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
L-alanyl-L-glutamine dipeptide +1 moredrug
Likely dose
L-alanyl-L-glutamine dipeptide 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04560309
NCT04560309Phase 3Completed

Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction

National Cardiovascular Center Harapan Kita Hospital Indonesia·interventional·Posted Sep 23, 2020·Updated Nov 13, 2023

In Brief

A Phase 3 clinical trial evaluating L-alanyl-L-glutamine dipeptide and Placebo for Coronary Artery Bypass and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting (CABG) is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart. Despite of improvement in operation techniques, cardioplegia, cardiopulmonary bypass (CPB), myocardial injury related to on-pump CABG is still prominent. In patient with low ejection fraction undergone on-pump CABG, myocardial injury is related to worse outcome and prognosis during peri-operative and post-operative period. On-pump CABG patients with low ejection fraction has increased (up to four times higher) post-operative in hospital mortality rate compared to patient with normal ejection fraction. Administration of intravenous glutamine had been documented in reducing myocardial damage during cardiac surgery and previous studies indicated that glutamine can protect against myocardial injury by various mechanism during ischemia and reperfusion. The purpose of this study to determine whether intravenous glutamine could prevent the decline of plasma glutamine level, reduce myocardial damage, improve hemodynamic profile, and reduce morbidity of on-pump CABG in patients with low ejection fraction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartJan 1, 2021
Primary CompletionOct 30, 2021
Study CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.8 years ago

Interventions

L-alanyl-L-glutamine dipeptidedrug

Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.

Placebodrug

Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.