Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: N(2)-L-Alanine L-Glutamine dipeptide

• Registration Number: NCT01478126
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Glutamine	N(2)-L-Alanine L-Glutamine dipeptide	Intravenous glutamine infusion perioperatively and 24 hours after surgery

Primary Outcome Measures

Name	Time	Method
Troponin I	Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation