Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
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.
DRUGPlacebo
Intravenous infusion of 0,9% solution of NaCl, rate=2\*weight/24. Infusion starts in operating room and ends next day after the surgery.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Troponin I | Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Intestinal fatty acid binding protein |
| 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 | alpha-glutathione s-transferase |
| 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 | — |
| 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 | Liver fatty acid binding protein |
| 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 | — |
| 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 | — |
Countries
Russia
Outcome results
None listed