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

Tracking Information
First Received Date ^ICMJE	November 16, 2011
Last Updated Date	August 26, 2012
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 21, 2011)	Troponin I [ Time Frame: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01478126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 21, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass
Official Title ^ICMJE	Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Drug: N(2)-L-Alanine L-Glutamine dipeptide Intravenous infusion of glutamine in total dose of 2 g/kg/day (rate=2weight/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=2weight/24. Infusion starts in operating room and ends next day after the surgery.
Study Arm (s)	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
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	December 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Russian Federation

Administrative Information
NCT Number ^ICMJE	NCT01478126
Other Study ID Numbers ^ICMJE	GOP 05
Has Data Monitoring Committee	No
Responsible Party	Meshalkin Research Institute of Pathology of Circulation
Study Sponsor ^ICMJE	Meshalkin Research Institute of Pathology of Circulation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Meshalkin Research Institute of Pathology of Circulation
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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