Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

Coronary Artery Disease Clinical Trial

Official title:

Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478126
• Other study ID #: GOP 05
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2011
• Last updated: October 30, 2013
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I		Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB	No
Secondary	Liver Fatty Acid Binding Protein	Liver fatty acid binding protein	Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	Intestinal fatty acid binding protein	Intestinal fatty acid binding protein	Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	alpha-glutathione s-transferase	alpha-glutathione s-transferase	Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	Alanine Aminotransferase (ALT)		Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	Aspartate transaminase (AST)		Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	Serum HSP-70		Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	Glutathione		Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No
Secondary	SH-groups		Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB	No

External Links

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