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Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

N(2)-L-Alanine L-Glutamine dipeptide

Placebo

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamine

Placebo

Arm Description

Intravenous glutamine infusion perioperatively and 24 hours after surgery

Outcomes

Primary Outcome Measures

Troponin I

Secondary Outcome Measures

Liver Fatty Acid Binding Protein

Liver fatty acid binding protein

Intestinal fatty acid binding protein

alpha-glutathione s-transferase

Alanine Aminotransferase (ALT)

Aspartate transaminase (AST)

Serum HSP-70

Glutathione

SH-groups

Full Information

NCT ID

NCT01478126

First Posted

November 16, 2011

Last Updated

October 30, 2013

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT01478126

Brief Title

Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Official Title

Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glutamine

Arm Type

Experimental

Arm Description

Intravenous glutamine infusion perioperatively and 24 hours after surgery

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

N(2)-L-Alanine L-Glutamine dipeptide

Other Intervention Name(s)

Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous infusion of 0,9% solution of NaCl, rate=2*weight/24. Infusion starts in operating room and ends next day after the surgery.

Primary Outcome Measure Information:

Title

Troponin I

Time Frame

Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB

Secondary Outcome Measure Information:

Title

Liver Fatty Acid Binding Protein

Description

Liver fatty acid binding protein

Time Frame