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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Criteria

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