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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Martin BRUTSCHE, Cantonal Hospital of St. Gallen.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703013
First Posted: October 10, 2012
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Martin BRUTSCHE, Cantonal Hospital of St. Gallen
  Purpose
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
Adrenal Insufficiency Inflammatory Lung Diseases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Martin BRUTSCHE, Cantonal Hospital of St. Gallen:

Biospecimen Retention:   Samples With DNA
Blood leukocytes, serum

Estimated Enrollment: 75
Study Start Date: January 2013
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: October 5, 2012
First Posted: October 10, 2012
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


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