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

Phase 1

Completed

• Conditions: Glycemic Control
• Interventions: Drug: B Low Dose GIK; Drug: C High Dose GIK; Drug: A IV Insulin drip

• Registration Number: NCT00460499
• Lead Sponsor: American Heart Association

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-12
• Study First Posted: 2007-04-16
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Diabetic CABG patients

Exclusion Criteria

• Renal and hepatic failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B Low dose GIK	B Low Dose GIK	This group will have low doses of glucose and insulin
C High Dose GIK	C High Dose GIK	This group will have high doses of insulin and glucose
A Insulin	A IV Insulin drip	This group will receive only an intravenous insulin infusion

Primary Outcome Measures

Name	Time	Method
glycemic control	24 hours following surgery
glycemic control, postoperative morbidity, inflammatory markers	24 hours following surgery

Secondary Outcome Measures

Name	Time	Method
free fatty acid levels	24 hours following surgery

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States