Clinical trial NCT01478126: Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass
Official title: Prospective Randomized Study of Glutamin Protective Properties in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-11-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Troponin I
timeFrame: Induction to anaesthesia, 30 min after cardiopulmonary bypass, 6, 24 hours after CPB
Secondary outcomes:
measure: Liver Fatty Acid Binding Protein
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: Intestinal fatty acid binding protein
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: alpha-glutathione s-transferase
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: Alanine Aminotransferase (ALT)
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: Aspartate transaminase (AST)
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: Serum HSP-70
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: Glutathione
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
measure: SH-groups
timeFrame: Induction to anaesthesia (0 hour of operation), before heparin injection (1 hour of operation), 5min after aorta unclaming, 2, 6, 24 hours after CPB
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
citation: 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.