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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:
ClinicalTrials.gov Identifier:
NCT01384656
First Posted: June 29, 2011
Last Update Posted: March 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384656


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

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
First Submitted: June 27, 2011
First Posted: June 29, 2011
Last Update Posted: March 6, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pharmaceutical Solutions
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs