Effect of Glucose-insulin-potassium Solution on Myocardial Protection During Off-pump Coronary Bypass Surgery in Patients With Acute Coronary Syndrome
1 other identifier
interventional
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 6, 2013
March 1, 2013
1 year
June 27, 2011
March 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
CK-MB(creatinine kinase-MB) mass
Comparison of cardiac enzyme elevation after surgery between GIK and Control group.
12 hours after the surgery
Study Arms (2)
GIK group
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients undergoing isolated OPCAB.
- Age: 20\~75.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 22986417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 6, 2013
Record last verified: 2013-03