Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo; Drug: N(2)-L-Alanine L-Glutamine dipeptide

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01478126

GOP 05

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Description:

Intravenous glutamine infusion perioperatively and 24 hours after surgery

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo