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

NCT ID: NCT01703013

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Brief Summary

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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

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Conditions

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Adrenal Insufficiency Inflammatory Lung Diseases

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Martin BRUTSCHE

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KSSG-Pneumo-0001

Identifier Type: -

Identifier Source: org_study_id