Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by American Heart Association. Recruitment status was Recruiting

First Received on December 18, 2007. No Changes Posted

Sponsor:	American Heart Association
Collaborator:	Eli Lilly and Company
Information provided by:	American Heart Association
ClinicalTrials.gov Identifier:	NCT00576394

Purpose

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.

Condition	Intervention	Phase
Glycemic Control	Drug: IV Insulin drip Drug: Insulin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Diabetes Medicines

Drug Information available for: Insulin Insulin beef Dextrose

U.S. FDA Resources

Further study details as provided by American Heart Association:

Primary Outcome Measures:

Incidence of Hypoglycemia [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

free fatty acid levels [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
Active Comparator: 1Moderate Glycemic Control Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl	Drug: IV Insulin drip IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
Active Comparator: 2Aggressive Glycemic Control Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl	Drug: Insulin IV insulin drip to keep serum glucose between 80-120mg/dl.

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

Patients with hepatic and renal failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576394

Contacts

Contact: Harold L Lazar	617-638-7352	harold.lazar@bmc.org
Contact: Carmel A Fitzgerald	617-638-7348	carmel.fitzgerald@bmc.org

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Harold L Lazar, MD 617-638-7350 harold.lazar@bmc.org

Sponsors and Collaborators

American Heart Association

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Harold L. Lazar MD, Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00576394 History of Changes
Other Study ID Numbers:	H-25760
Study First Received:	December 18, 2007
Last Updated:	December 18, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by American Heart Association:

Glucose, Insulin

Additional relevant MeSH terms:

Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012