Diabetes in the Perioperative Period

NCT ID: NCT00738114

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

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.

Conditions

Hyperglycemia; Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients

No interventions assigned to this group

2

group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria

• outpatient procedures, cardiac surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Universiy Hospital

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20435798 (View on PubMed)

Other Identifiers

IRB00011938

Identifier Type: -

Identifier Source: org_study_id