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

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01703013
• Other study ID #: KSSG-Pneumo-0001
• Status: Not yet recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 9, 2012
• Start date: January 2013

Study information

• Verified date: October 2012
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics Committee of the Canton St. Gallen
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Inflammatory Lung Diseases
• Lung Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen