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

NCT ID: NCT01384656

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GIK group

Group Type EXPERIMENTAL

GIK solution

Intervention Type DRUG

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.

Control group

Group Type PLACEBO_COMPARATOR

GIK solution

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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glucose-insulin-potassium(GIK) solution

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22986417 (View on PubMed)

Other Identifiers

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4-2009-0689

Identifier Type: -

Identifier Source: org_study_id

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