Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients - Full Text View

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

MedlinePlus related topics:

Coronary Artery Bypass Surgery

ChemIDplus related topics:

Insulin Sodium chloride Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

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
1Moderate Glycemic Control: Active Comparator 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
2Aggressive Glycemic Control: Active Comparator 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

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

Keywords provided by American Heart Association:

Glucose, Insulin

Study placed in the following topic categories:

Aggression

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

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