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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: GIK solution

• Registration Number: NCT01384656
• Lead Sponsor: Yonsei University

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 available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GIK group	GIK solution	-
Control group	GIK solution	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of