Diabetes in the Perioperative Period
| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2008 | ||||
| Last Updated Date | April 9, 2010 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery. [ Time Frame: 01/01/07 - 06/30/2007 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00738114 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery [ Time Frame: 01/01/07 - 06/30/2007 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diabetes in the Perioperative Period | ||||
| Official Title ICMJE | Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome | ||||
| Brief Summary | High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. High blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery. |
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| Detailed Description | We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Frisch A, Chandra P, Smiley D, Peng L, Rizzo M, Gatcliffe C, Hudson M, Mendoza J, Johnson R, Lin E, Umpierrez GE. Prevalence and clinical outcome of hyperglycemia in the perioperative period in noncardiac surgery. Diabetes Care. 2010 Aug;33(8):1783-8. Epub 2010 Apr 30. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00738114 | ||||
| Other Study ID Numbers ICMJE | 11938 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Guillermo Umpierrez, MD Professor of Medicine, Emory University School of Medicine | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | April 2010 | ||||
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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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