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

• Conditions: Inflammatory Lung Diseases; Adrenal Insufficiency

• Registration Number: NCT01703013
• Lead Sponsor: Cantonal Hospital of St. Gallen

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Study First Posted: 2012-10-10
• Last Update Posted: 2012-10-10
• Study Start: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified