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Sponsors and Collaborators: |
American Heart Association Eli Lilly and Company |
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Information provided by: | American Heart Association |
ClinicalTrials.gov Identifier: | NCT00576394 |
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 |
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Glycemic Control |
Drug: IV Insulin drip Drug: Insulin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients |
Estimated Enrollment: | 150 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
---|---|
1Moderate Glycemic Control: Active Comparator
Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
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Drug: IV Insulin drip
IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl
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2Aggressive Glycemic Control: Active Comparator
Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl
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Drug: Insulin
IV insulin drip to keep serum glucose between 80-120mg/dl.
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Harold L Lazar | 617-638-7352 | harold.lazar@bmc.org |
Contact: Carmel A Fitzgerald | 617-638-7348 | carmel.fitzgerald@bmc.org |
United States, Massachusetts | |
Boston Medical Center | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Harold L Lazar, MD 617-638-7350 harold.lazar@bmc.org |
Responsible Party: | Boston Medical Center ( Harold L. Lazar MD ) |
Study ID Numbers: | H-25760 |
Study First Received: | December 18, 2007 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00576394 |
Health Authority: | United States: Institutional Review Board |
Glucose, Insulin |
Aggression Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |