Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Study Overview
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Brief Summary
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The purpose of this study is to determine whether perioperative glutamine administration possess protective properties on internal organs (heart and gut) in patients with coronary atherosclerosis, operated under cardiopulmonary bypass.

Official Title
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Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: N(2)-L-Alanine L-Glutamine dipeptide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with coronary artery disease operated on under cardiopulmonary bypass Exclusion Criteria: Ejection fraction<40% Viral hepatitis Liver cirrhosis Cholecystitis Pancreatitis Chronic severe gastrointestinal disease Surgery on gastrointestinal tract in patient's medical history

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>Intravenous glutamine infusion perioperatively and 24 hours after surgery | Drug: N(2)-L-Alanine L-Glutamine dipeptide<br>* Intravenous infusion of glutamine in total dose of 2 g/kg/day (rate=2*weight/24 ml/h). Infusion starts in operating room and ends next day after the surgery.<br>* Other names: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intravenous infusion of 0,9% solution of NaCl, rate=2*weight/24. Infusion starts in operating room and ends next day after the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin I |  | Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Fatty Acid Binding Protein | Liver fatty acid binding protein | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| Intestinal fatty acid binding protein | Intestinal fatty acid binding protein | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| alpha-glutathione s-transferase | alpha-glutathione s-transferase | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| Alanine Aminotransferase (ALT) |  | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| Aspartate transaminase (AST) |  | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| Serum HSP-70 |  | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| Glutathione |  | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB | 
| SH-groups |  | Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB |