Phase 3 N=60 Randomized Quadruple-blind Treatment

Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF

Coronary Artery Bypass · Cardiopulmonary Bypass · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT04560309 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Plasma Troponin I at Baseline — 0.42; 0.17 ng/mL — p=0.993

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: L-alanyl-L-glutamine dipeptide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Troponin I at Baseline	0.42; 0.17	0.993
PRIMARY Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass	1.72; 1.68	0.883
PRIMARY Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass	3.43; 4.41	0.034 sig
PRIMARY Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass	3.08; 3.77	0.038 sig
PRIMARY Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass	1.66; 1.75	0.423
PRIMARY Plasma Glutamine at Baseline	555.09; 632.24	0.216
PRIMARY Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass	935.42; 634.79	0.001 sig
SECONDARY Right Atrial Appendage Alpha-ketoglutarate	674.93; 507.32	0.043 sig
SECONDARY Right Atrial Appendage Myocardial Injury Score	1.30; 1.48	0.011 sig
SECONDARY Right Atrial Appendage Apoptosis Index	5.00; 6.17	0.975
SECONDARY Anti Cardiac Troponin I Expression	-0.33; -0.83	0.031 sig
SECONDARY Ejection Fraction	46.17; 45.55	0.645
SECONDARY Ejection Fraction	46.17; 45.55	0.645
SECONDARY Cardiac Index	2.00; 1.87; 3.15; 3.03; 2.45; 2.36	0.330
SECONDARY Plasma Lactate Before Induction to Anesthesia	1.40; 1.30	0.200
SECONDARY Plasma Lactate 5 Minute After Cardiopulmonary Bypass	2.02; 2.08	0.720
SECONDARY Plasma Lactate 6 Hours After Cardiopulmonary Bypass	5.30; 5.70	0.042 sig
SECONDARY Plasma Lactate 24 Hours After Cardiopulmonary Bypass	2.08; 2.46	0.044 sig
SECONDARY Plasma Lactate 48 Hours After Cardiopulmonary Bypass	2.13; 2.28	0.349
SECONDARY Intensive Care Unit Ventilation Time	652.82; 656.82	0.950
SECONDARY Intensive Care Unit Length of Stay	20.00; 20.00	0.862
SECONDARY Vasoactive Inotropic Score	5.00; 5.00	0.075

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04560309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.