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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014