Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

Glycemic Control Clinical Trial

Official title:

Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576394
• Other study ID #: H-25760
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2007
• Last updated: June 22, 2015
• Start date: October 2006
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: American Heart Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

• Patients with hepatic and renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glycemic Control

Intervention

Drug:
• IV Insulin drip
IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
• Insulin
IV insulin drip to keep serum glucose between 80-120mg/dl.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
American Heart Association	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hypoglycemia		24 hours following surgery	Yes
Secondary	free fatty acid levels		24 hours following surgery	No