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NCT01384656 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01384656
Other study ID # 4-2009-0689
Secondary ID
Status Completed
Phase Phase 4
First received June 27, 2011
Last updated March 4, 2013
Start date February 2011
Est. completion date February 2012

Study information
Verified date March 2013
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary CK-MB(creatinine kinase-MB) mass Comparison of cardiac enzyme elevation after surgery between GIK and Control group. 12 hours after the surgery No
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