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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01384656
First received: June 27, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
 Drug: GIK solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • CK-MB(creatinine kinase-MB) mass [ Time Frame: 12 hours after the surgery ] [ Designated as safety issue: No ]
    Comparison of cardiac enzyme elevation after surgery between GIK and Control group.


Enrollment: 66
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: glucose-insulin-potassium(GIK) solution
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 Name: glucose-insulin-potassium(GIK) solution

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384656

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01384656     History of Changes
Other Study ID Numbers: 4-2009-0689
Study First Received: June 27, 2011
Last Updated: March 4, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
 Pain
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013