Diabetes in the Perioperative Period
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Purpose
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.
| Condition |
|---|
|
Hyperglycemia Diabetes |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome |
- 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 ]
- 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 ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients
|
|
2
group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients
|
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.
Eligibility| 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:
- patient undergoing non-cardiac surgery (inpatient only)
Exclusion Criteria:
- outpatient procedures, cardiac surgery
Contacts and Locations More Information
No publications provided by Emory University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guillermo Umpierrez, MD Professor of Medicine, Emory University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00738114 History of Changes |
| Other Study ID Numbers: | 11938 |
| Study First Received: | August 19, 2008 |
| Last Updated: | April 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
non-cardiac surgery mortality |
morbidity perioperative period |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013