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
  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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00738114     History of Changes
Other Study ID Numbers: IRB00011938
Study First Received: August 19, 2008
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
non-cardiac
surgery
mortality
morbidity
perioperative
period

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014