Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

NCT ID: NCT01478126

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Glutamine

Intravenous glutamine infusion perioperatively and 24 hours after surgery

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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

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

Placebo

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

Intervention Type DRUG

Other Intervention Names

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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Lomivorotov VV, Efremov SM, Shmirev VA, Ponomarev DN, Lomivorotov VN, Karaskov AM. Glutamine is cardioprotective in patients with ischemic heart disease following cardiopulmonary bypass. Heart Surg Forum. 2011 Dec;14(6):E384-8. doi: 10.1532/HSF98.20111074.

Reference Type BACKGROUND
PMID: 22167767 (View on PubMed)

Other Identifiers

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GOP 05

Identifier Type: -

Identifier Source: org_study_id