Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
Condition: Coronary Artery Bypass; Cardiopulmonary Bypass; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: L-alanyl-L-glutamine dipeptide; Placebo
Intervention description: 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.; Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glutamine; Myocardial protection; Coronary artery bypass grafting; Cardiopulmonary bypass; Low ejection fraction; Myocardial injury

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.
    

Eligibility 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