The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

NCT01703013 | Unknown

• 1 other identifier: KSSG-Pneumo-0001
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear. In a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with COPD and pneumonia).

Conditions

Adrenal Insufficiency; Inflammatory Lung Diseases

Keywords

Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)

You may qualify if:

• Patients 18-80 yo
• Patients diagnosed with pneumonia or exacerbated COPD
• Healthy controls 18-80yo
• Signed informed consent

You may not qualify if:

• Pregnant or lactating females
• Life threatening severe disease
• Known primary or secondary adrenal insufficiency
• Systemic steroid therapy in the last 8 weeks
• Systemic therapy with opioid
• Systemic therapy with Ketoconazol, Mitotane, Metopyron, Etomidat, Rifampicin
• In healthy controls: relevant respiratory disease or known adrenal insufficiency or indication of infection
• Allergic reaction to ACTH
• Missing informed consent

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood leukocytes, serum

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: January 1, 2013
• Last Updated: October 10, 2012

Record last verified: 2012-10