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Diabetes in the Perioperative Period

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ClinicalTrials.gov Identifier: NCT00738114
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Description
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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.

Condition or disease
Hyperglycemia Diabetes

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.
Study Design
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Study Type : Observational
Actual Enrollment : 3184 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 01/01/07 - 06/30/2007 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Georgia
Emory Universiy Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Guillermo Umpierrez, MD Emory University
More Information
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Publications of Results:

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Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00738114    
Other Study ID Numbers: IRB00011938
First Posted: August 20, 2008    Key Record Dates
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:
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Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases