Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

American Heart Association (AHA)

Status and phase: Completed; Phase 1

Conditions: Glycemic Control

Treatments: Drug: B Low Dose GIK; Drug: A IV Insulin drip; Drug: C High Dose GIK

Study type: Interventional

Funder types: Other

Identifiers

NCT00460499

H-23735

Details and patient eligibility

About

This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Full description

Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Enrollment: 250 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic CABG patients

Exclusion criteria

• Renal and hepatic failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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250 participants in 3 patient groups

B Low dose GIK

Active Comparator group

Description:

This group will have low doses of glucose and insulin

Treatment:

Drug: B Low Dose GIK

C High Dose GIK

Active Comparator group

Description:

This group will have high doses of insulin and glucose

Treatment:

Drug: C High Dose GIK

A Insulin

Active Comparator group

Description:

This group will receive only an intravenous insulin infusion

Treatment:

Drug: A IV Insulin drip