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

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ClinicalTrials.gov Identifier: NCT01703013
Recruitment Status : Unknown
Verified October 2012 by Martin BRUTSCHE, Cantonal Hospital of St. Gallen.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Martin BRUTSCHE, 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).

Condition or disease
Adrenal Insufficiency Inflammatory Lung Diseases

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
Study Start Date : January 2013





Biospecimen Retention:   Samples With DNA
Blood leukocytes, serum


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)
Criteria

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

Responsible Party: Martin BRUTSCHE, Prof., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01703013     History of Changes
Other Study ID Numbers: KSSG-Pneumo-0001
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Martin BRUTSCHE, Cantonal Hospital of St. Gallen:
Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency

Additional relevant MeSH terms:
Lung Diseases
Adrenal Insufficiency
Respiratory Tract Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Defensins
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Infective Agents