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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2012

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: GIK group
  • Placebo Comparator: Control group

Clinical Trial Outcome Measures

Primary Measures

  • CK-MB(creatinine kinase-MB) mass
    • Time Frame: 12 hours after the surgery
    • Comparison of cardiac enzyme elevation after surgery between GIK and Control group.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.