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Diabetes in the Perioperative Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00738114
First received: August 19, 2008
Last updated: November 20, 2013
Last verified: November 2013

August 19, 2008
November 20, 2013
August 2008
December 2009   (final data collection date for primary outcome 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. [ Time Frame: 01/01/07 - 06/30/2007 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738114 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Diabetes in the Perioperative Period
Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

  • Hyperglycemia
  • Diabetes
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3184
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

  • outpatient procedures, cardiac surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00738114
IRB00011938
No
Guillermo Umpierrez, Emory University
Emory University
Not Provided
Principal Investigator: Guillermo Umpierrez, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP