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OpenTrials
Completed

NCT Number: NCT01384656

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIK solution

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.

Other names: glucose-insulin-potassium(GIK) solution

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2011
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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