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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
October 5, 2012
October 10, 2012
October 10, 2012
January 2013
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No Changes Posted
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The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
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).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Blood leukocytes, serum
Non-Probability Sample
Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)
  • Adrenal Insufficiency
  • Inflammatory Lung Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
75
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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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01703013
KSSG-Pneumo-0001
No
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Martin BRUTSCHE, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
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Not Provided
Cantonal Hospital of St. Gallen
October 2012