Diabetes in the Perioperative Period

Diabetes Clinical Trial

Official title:

Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738114
• Other study ID #: IRB00011938
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: November 20, 2013
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3184
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

• outpatient procedures, cardiac surgery

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Locations

Country	Name	City	State
United States	Emory Universiy Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery.		01/01/07 - 06/30/2007	No
Secondary	determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery		01/01/07 - 06/30/2007	No