Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00605007
First received: January 17, 2008
Last updated: November 20, 2013
Last verified: April 2010
  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.


Condition
COPD

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:


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 ]

Enrollment: 450
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

No publications provided

Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00605007     History of Changes
Other Study ID Numbers: IRB00001392, e1392
Study First Received: January 17, 2008
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
COPD
Diabetes
Respiratory Disorders

Additional relevant MeSH terms:
Hyperglycemia
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014