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Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576394
First Posted: December 19, 2007
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Harold L. Lazar MD, American Heart Association
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Harold L. Lazar MD, American Heart Association:

Primary Outcome Measures:
  • Incidence of Hypoglycemia [ Time Frame: 24 hours following surgery ]

Secondary Outcome Measures:
  • free fatty acid levels [ Time Frame: 24 hours following surgery ]

Enrollment: 108
Study Start Date: October 2006
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576394


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
American Heart Association
Eli Lilly and Company
  More Information

Publications:
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
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Harold L. Lazar MD, American Heart Association:
Glucose, Insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs