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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 July 2012 by American Heart Association.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Harold L. Lazar MD, American Heart Association
ClinicalTrials.gov Identifier:
NCT00576394
First received: December 18, 2007
Last updated: July 17, 2012
Last verified: July 2012

December 18, 2007
July 17, 2012
October 2006
June 2014   (final data collection date for primary outcome measure)
Incidence of Hypoglycemia [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00576394 on ClinicalTrials.gov Archive Site
free fatty acid levels [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Glycemic Control
  • Drug: IV Insulin drip
    IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
  • Drug: Insulin
    IV insulin drip to keep serum glucose between 80-120mg/dl.
  • Active Comparator: 1Moderate Glycemic Control
    Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
    Intervention: Drug: IV Insulin drip
  • Active Comparator: 2Aggressive Glycemic Control
    Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl
    Intervention: Drug: Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

  • Patients with hepatic and renal failure
Both
18 Years to 90 Years
No
Contact: Harold L Lazar 617-638-7352 harold.lazar@bmc.org
Contact: Carmel A Fitzgerald 617-638-7348 carmel.fitzgerald@bmc.org
United States
 
NCT00576394
H-25760
Yes
Harold L. Lazar MD, American Heart Association
American Heart Association
Eli Lilly and Company
Not Provided
American Heart Association
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP