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Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01478126
First received: November 16, 2011
Last updated: August 26, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: N(2)-L-Alanine L-Glutamine dipeptide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Troponin I [ Time Frame: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • L-FABP [ 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 ] [ Designated as safety issue: No ]
    Liver fatty acid binding protein

  • I-FABP [ 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 ] [ Designated as safety issue: No ]
    Intestinal fatty acid binding protein

  • α-CST [ 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 ] [ Designated as safety issue: No ]
    alpha-glutathione s-transferase

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glutamine
Intravenous glutamine infusion perioperatively and 24 hours after surgery
 Drug: 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.
Other Name: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Placebo Comparator: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478126

Locations
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

Publications:

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01478126     History of Changes
Other Study ID Numbers: GOP 05
Study First Received: November 16, 2011
Last Updated: August 26, 2012
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013