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Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01478126
First received: November 16, 2011
Last updated: October 30, 2013
Last verified: October 2013

November 16, 2011
October 30, 2013
January 2012
December 2012   (final data collection date for primary outcome measure)
Troponin I [ Time Frame: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01478126 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Liver fatty acid binding protein
  • 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 ] [ Designated as safety issue: No ]
    Intestinal fatty acid binding protein
  • 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 ] [ 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 ]
  • 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 ]
Not Provided
Not Provided
 
Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass
Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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)
  • 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.
  • Experimental: Glutamine
    Intravenous glutamine infusion perioperatively and 24 hours after surgery
    Intervention: Drug: N(2)-L-Alanine L-Glutamine dipeptide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01478126
GOP 05
No
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP