Back to resultsAggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Primary Purpose
Glycemic Control
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IV Insulin drip
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Glycemic Control focused on measuring Glucose, Insulin
Eligibility Criteria
Inclusion Criteria:
- All diabetic patients undergoing Coronary Bypass Surgery
Exclusion Criteria:
- Patients with hepatic and renal failure
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1Moderate Glycemic Control
2Aggressive Glycemic Control
Arm Description
Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl
Outcomes
Primary Outcome Measures
Incidence of Hypoglycemia
Secondary Outcome Measures
free fatty acid levels
Full Information
NCT ID
NCT00576394
First Posted
December 18, 2007
Last Updated
June 22, 2015
Sponsor
American Heart Association
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00576394
Brief Title
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Official Title
Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American Heart Association
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycemic Control
Keywords
Glucose, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1Moderate Glycemic Control
Arm Type
Active Comparator
Arm Description
Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
Arm Title
2Aggressive Glycemic Control
Arm Type
Active Comparator
Arm Description
Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl
Intervention Type
Drug
Intervention Name(s)
IV Insulin drip
Intervention Description
IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
IV insulin drip to keep serum glucose between 80-120mg/dl.
Primary Outcome Measure Information:
Title
Incidence of Hypoglycemia
Time Frame
24 hours following surgery
Secondary Outcome Measure Information:
Title
free fatty acid levels
Time Frame
24 hours following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All diabetic patients undergoing Coronary Bypass Surgery
Exclusion Criteria:
Patients with hepatic and renal failure
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21865944
Citation
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.
Results Reference
result
Learn more about this trial
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
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