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

March 4, 2013 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
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 Names:
  • glucose-insulin-potassium(GIK) solution
Experimental: GIK group
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 Names:
  • glucose-insulin-potassium(GIK) solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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