Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

This study is currently recruiting participants.
Verified July 2012 by American Heart Association
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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1Moderate Glycemic Control
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
Active Comparator: 2Aggressive Glycemic Control
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

No publications provided

Responsible Party: Harold L. Lazar MD, Professor of Cardiothoracic Surgery, American Heart Association
ClinicalTrials.gov Identifier: NCT00576394     History of Changes
Other Study ID Numbers: H-25760
Study First Received: December 18, 2007
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Heart Association:
Glucose, Insulin

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014