NCT01478126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

November 16, 2011

Last Update Submit

October 30, 2013

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Troponin I

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

Secondary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Glutamine

EXPERIMENTAL

Intravenous glutamine infusion perioperatively and 24 hours after surgery

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

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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

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.

Also known as: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Glutamine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with coronary artery disease operated on under cardiopulmonary bypass

You may not qualify if:

  • Ejection fraction\<40%
  • Viral hepatitis
  • Liver cirrhosis
  • Cholecystitis
  • Pancreatitis
  • Chronic severe gastrointestinal disease
  • Surgery on gastrointestinal tract in patient's medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, Russia

Location

Related Publications (1)

  • 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.

    PMID: 22167767BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 23, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

September 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

RU(1)