Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF (NCT04560309) | Clinical Trial Compass
CompletedPhase 3
Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
Indonesia60 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with coronary heart disease indicated for elective coronary artery bypass grafting under cardiopulmonary bypass
* Patients with left ventricle ejection fraction 31% -50% confirmed by echocardiography or radio nuclear study.
* Patients age ≥18 years
* Never had heart surgery before
* Agree to participate in the study and signed informed consent
Exclusion Criteria:
* Emergency coronary artery grafting bypass
* Having additional procedures other than coronary artery bypass grafting
* History of myocardial infarction with onset less than 3 months
* Patients with serum creatinine level more than 2 g/dL
* Patients with ALT/AST levels more than 1.5 times the upper limit of normal value
* Required to use intra-aortic balloon pump pre-operatively
* History of stroke with onset less than 3 months
* History of pre-operative atrial fibrillation
* History of heart conduction problem and/or using a pacemaker
* Patients with HIV
* Contraindications to pulmonary artery catheter insertion
Drop out Criteria
* Experiencing stroke after surgery
* Experiencing surgery related complication (haemorrhage) requiring re operation
* Requiring continuous veno-venous hemofiltration or haemodialysis after surgery
* Delayed sternal closure
* Aortic cross clamp duration more than 120 minutes and/or cardiopulmonary bypass time more than 180 minutes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Troponin I at Baseline
Timeframe: Before induction to anesthesia
2
Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass
Timeframe: 5 minute after cardiopulmonary bypass
3
Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass
Timeframe: 6 hour after cardiopulmonary bypass
4
Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass
Timeframe: 24 hour after cardiopulmonary bypass
5
Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass
Timeframe: 48 hour after cardiopulmonary bypass
6
Plasma Glutamine at Baseline
Timeframe: Before induction to anesthesia
7
Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass
Timeframe: 24 hour after cardiopulmonary bypass
Trial details
NCT IDNCT04560309
SponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia