Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

This study has been completed.
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: June 22, 2015
Last verified: June 2015

December 18, 2007
June 22, 2015
October 2006
June 2015   (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
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: 10.1097/SLA.0b013e31822c5d78.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2015
June 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576394
H-25760
Yes
Not Provided
Not Provided
Harold L. Lazar MD, American Heart Association
American Heart Association
Eli Lilly and Company
Not Provided
American Heart Association
June 2015

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