Diabetes in the Perioperative Period

NCT00738114 | Completed

• 1 other identifier: IRB00011938
• Study Type: observational
• Target: 3,184
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Diabetes

Keywords

non-cardiac; surgery; mortality; morbidity; perioperative; period

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007

You may qualify if:

• patient undergoing non-cardiac surgery (inpatient only)

You may not qualify if:

• outpatient procedures, cardiac surgery

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Universiy Hospital

Atlanta, Georgia, 30322, United States

Location

Related 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: 10.2337/dc10-0304. Epub 2010 Apr 30.

  PMID: 20435798 RESULT

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)