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Study on COPD Corticosteroid-Induced Hyperglycemia on Clinical Outcome in Patients With COPD
This study is ongoing, but not recruiting participants.
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00605007
  Purpose

Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.

Hypotheses:

We hypothesize that COPD patients with corticosteroid-induced hyperglycemia experience higher morbidity (infections, ventilator associated pneumonia, length of stay, acute renal failure) and mortality compared to COPD patients with normal glucose levels.

Specific Aim:

To determine the impact of corticosteroid-induced hyperglycemia on clinical outcome (length of stay, disposition, APACHE score, need for ventilatory support and ICU admission, mortality) in patients with COPD exacerbation.


Condition
COPD
Corticosteroid-Induced Hyperglycemia

MedlinePlus related topics: Diabetes
Drug Information available for: Corticosteroids
U.S. FDA Resources
Study Type: Observational
Study Design: Retrospective
Official Title: The Impact of Corticosteroid-Induced Hyperglycemia on Clinical Outcome (Length of Stay, Disposition, APACHE Score, Need for Ventilatory Support and ICU Admission, Mortality) in Patients With COPD Exacerbation

Further study details as provided by Emory University:

Primary Outcome Measures:
  • The primary outcome of the study is to determine the mortality rate of COPD patients with corticosteroid-induce hyperglycemia. [ Time Frame: once all charts have been reviews ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 450
Study Start Date: November 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted with COPD exacerbation at Atlanta Medical Center and Grady Memorial Hospital

Criteria

Inclusion Criteria:

  • Patients admitted with COPD exacerbation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605007

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
  More Information

Responsible Party: Emory University School of Medicine ( Guillermo Umpierrez, MD )
Study ID Numbers: e1392, e1392
Study First Received: January 17, 2008
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00605007  
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
COPD
Diabetes
Respiratory Disorders

Study placed in the following topic categories:
Lung Diseases, Obstructive
Metabolic Diseases
Hyperglycemia
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Diabetes Mellitus
Metabolic disorder
Glucose Metabolism Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009