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Clinical Trials/NCT00899483
NCT00899483
Unknown
Not Applicable

Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

University Hospital Birmingham1 site in 1 country100 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Glucose potassium insulin solution
Conditions
Type 2 Diabetes
Sponsor
University Hospital Birmingham
Enrollment
100
Locations
1
Primary Endpoint
The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study
Last Updated
16 years ago

Overview

Brief Summary

The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2012
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Birmingham

Eligibility Criteria

Inclusion Criteria

  • Type II diabetes mellitus patients (as defined by WHO)
  • Diet, oral hypoglycaemic or insulin therapy
  • Undergoing elective and urgent coronary artery bypass surgery

Exclusion Criteria

  • Non-diabetics
  • Emergency and redo CABG
  • \< 18 years
  • Pregnancy
  • Dialysis-dependence
  • History of CVA/TIA \< 6 months
  • Heart valve disease requiring surgery
  • STEMI \< 3 months

Arms & Interventions

1

Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L

Intervention: Glucose potassium insulin solution

Outcomes

Primary Outcomes

The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study

Time Frame: 3 months post CABG

Secondary Outcomes

  • Glycaemic control will be assessed 2 hours pre-operatively and 72 hours post-operatively. Measurement timings will be standardized allowing comparison of glycaemic control during different time-periods.(72 hours post CABG)

Study Sites (1)

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