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Diabetes in the Perioperative Period

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00738114

First Posted: August 20, 2008

Last Update Posted: November 21, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Guillermo Umpierrez, Emory University

Purpose

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.

Condition
Hyperglycemia Diabetes


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome

Resource links provided by NLM:

MedlinePlus related topics: Hyperglycemia

U.S. FDA Resources

Further study details as provided by Guillermo Umpierrez, Emory University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	3184
Study Start Date:	August 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

outpatient procedures, cardiac surgery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738114

Locations


United States, Georgia
Emory Universiy Hospital
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators


Principal Investigator:	Guillermo Umpierrez, MD	Emory University

More Information

Publications:

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.


Responsible Party:	Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier:	NCT00738114 History of Changes
Other Study ID Numbers:	IRB00011938
First Submitted:	August 19, 2008
First Posted:	August 20, 2008
Last Update Posted:	November 21, 2013
Last Verified:	November 2013

Keywords provided by Guillermo Umpierrez, Emory University:


non-cardiac surgery mortality	morbidity perioperative period

Additional relevant MeSH terms:


Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

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