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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00576394
Other study ID # H-25760
Secondary ID
Status Completed
Phase Phase 1
First received December 18, 2007
Last updated June 22, 2015
Start date October 2006
Est. completion date June 2015

Study information

Verified date June 2015
Source American Heart Association
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

- Patients with hepatic and renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
IV Insulin drip
IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
Insulin
IV insulin drip to keep serum glucose between 80-120mg/dl.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
American Heart Association Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Hypoglycemia 24 hours following surgery Yes
Secondary free fatty acid levels 24 hours following surgery No
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