Clinical trial NCT00738114: Diabetes in the Perioperative Period
Official title: Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Diabetes
Keywords: non-cardiac
surgery
mortality
morbidity
perioperative
period
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 3184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007

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.

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 criteria: Inclusion Criteria:

* patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

* outpatient procedures, cardiac surgery

Primary outcomes:
measure: assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery.
timeFrame: 01/01/07 - 06/30/2007
Secondary outcomes:
measure: determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery
timeFrame: 01/01/07 - 06/30/2007
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Universiy Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2337/dc10-0304. Epub 2010 Apr 30.