Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01384656

First received: June 27, 2011

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 27, 2011
Last Updated Date	March 4, 2013
Start Date ^ICMJE	February 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 27, 2011)	CK-MB(creatinine kinase-MB) mass [ Time Frame: 12 hours after the surgery ] [ Designated as safety issue: No ] Comparison of cardiac enzyme elevation after surgery between GIK and Control group.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01384656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
Official Title ^ICMJE	Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
Brief Summary	Patients undergoing multivessel off-pump coronary bypass surgery (OPCAB) inevitably experience cumulative ischemia-reperfusion injury at myocardium. Glucose-insulin-potassium (GIK) is a potentially useful adjunct to myocardial protection. This study was designed to evaluate the effects of GIK infusion on myocardium in patients undergoing OPCAB. Patients undergoing OPCAB with acute coronary syndrome are randomly assigned to GIK or Control group. The trial is double-blind and conducted at a single center.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Acute Coronary Syndrome
Intervention ^ICMJE	Drug: GIK solution Patients receive 0.3 ml/kg/hr GIK solution or the same volume of normal saline depending on the group during off-pump coronary bypass surgery. GIK solution consist of 50% glucose, potassium 80 mEq, and regular insulin 325 IU/500ml. Other Name: glucose-insulin-potassium(GIK) solution
Study Arm (s)	Experimental: GIK group Intervention: Drug: GIK solution Placebo Comparator: Control group Intervention: Drug: GIK solution
Publications *	Shim JK, Yang SY, Yoo YC, Yoo KJ, Kwak YL. Myocardial protection by glucose-insulin-potassium in acute coronary syndrome patients undergoing urgent multivessel off-pump coronary artery bypass surgery. Br J Anaesth. 2013 Jan;110(1):47-53. doi: 10.1093/bja/aes324. Epub 2012 Sep 17.
* 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	Completed
Enrollment ^ICMJE	66
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients undergoing isolated OPCAB. Age: 20~75. Exclusion Criteria: Emergency operation. Patients with MR ≥ 2. Patients with IDDM. Patients with random sugar ≥ 250 mg/dL. Patients with serum creatinine ≥ 2.0 mg/dL. Patients with acute myocardial infarction within 1 week of surgery
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01384656
Other Study ID Numbers ^ICMJE	4-2009-0689
Has Data Monitoring Committee	No
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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