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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00738114 |
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. 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.
Condition |
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Hyperglycemia Diabetes |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome |
Estimated Enrollment: | 1500 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients
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2
group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007
Inclusion Criteria:
Exclusion Criteria:
Contact: Guillermo Umpierrez, MD | 404-778-1665 | geumpie@emory.edu |
Contact: Anna Frisch, MD, PhD | 404-219-7814 | afrisch@emory.edu |
United States, Georgia | |
Emory Universiy Hospital | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Anna Firsch, MD, PhD 404-219-7814 afrisch@emory.edu | |
Contact: Natasha Khazai, MD 404-778-1687 nkhazai@emory.edu |
Principal Investigator: | Guillermo Umpierrez, MD | Emory University |
Responsible Party: | Emory University School of Medicine ( Guillermo Umpierrez, MD Professor of Medicine ) |
Study ID Numbers: | 11938 |
Study First Received: | August 19, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00738114 |
Health Authority: | United States: Institutional Review Board |
non-cardiac surgery mortality |
morbidity perioperative period |
Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |