Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting? (GUIDE)

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Drug: Glucose potassium insulin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00899483

RRK3545

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Glucose potassium insulin solution

2

No Intervention group

Description:

Normal departmental practice using dextrose insulin infusion