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Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01478126
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.
Study Start Date : January 2012
Primary Completion Date : December 2012
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Troponin I [ Time Frame: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478126


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

Additional Information:
Publications:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01478126     History of Changes
Other Study ID Numbers: GOP 05
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

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