This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

This study has been completed.
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: June 22, 2015
Last verified: June 2015
  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

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
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

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
Study First Received: December 18, 2007
Last Updated: June 22, 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

ClinicalTrials.gov processed this record on September 21, 2017