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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 18, 2007 | ||||||||
| Last Updated Date | December 18, 2007 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of Hypoglycemia [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
free fatty acid levels [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients | ||||||||
| Official Title ICMJE | Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Glycemic Control | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00576394 | ||||||||
| Responsible Party | Harold L. Lazar MD, Boston Medical Center | ||||||||
| Study ID Numbers ICMJE | H-25760 | ||||||||
| Study Sponsor ICMJE | American Heart Association | ||||||||
| Collaborators ICMJE | Eli Lilly and Company | ||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | American Heart Association | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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