Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

Phase 1

Completed

• Conditions: Glycemic Control
• Interventions: Drug: IV Insulin drip; Drug: Insulin

• Registration Number: NCT00576394
• Lead Sponsor: American Heart Association

Brief Summary

entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

Detailed Description

150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria

• Patients with hepatic and renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1Moderate Glycemic Control	IV Insulin drip	Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
2Aggressive Glycemic Control	Insulin	Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl

Primary Outcome Measures

Name	Time	Method
Incidence of Hypoglycemia	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