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Completed

NCT Number: NCT01478126

Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Research Institute of Circulation Pathology

Novosibirsk, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)

Placebo

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.

Primary outcomes

  1. Troponin I

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

Secondary outcomes

  1. Liver Fatty Acid Binding Protein

    Time frame: 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

  2. Intestinal fatty acid binding protein

    Time frame: 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

  3. alpha-glutathione s-transferase

    Time frame: 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

  4. Alanine Aminotransferase (ALT)

    Time frame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB

  5. Aspartate transaminase (AST)

    Time frame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB

  6. Serum HSP-70

    Time frame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB

  7. Glutathione

    Time frame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB

  8. SH-groups

    Time frame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 23, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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