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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605007
• Other study ID #: IRB00001392
• Secondary ID: e1392
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: November 20, 2013
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years
• Eligibility: Inclusion Criteria: Patients admitted with COPD exacerbation

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• COPD
• Hyperglycemia

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of the study is to determine the mortality rate of COPD patients with corticosteroid-induce hyperglycemia.		once all charts have been reviews	Yes