Trial record 2 of 30 for:    Open Studies | "Adrenal Insufficiency"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Martin BRUTSCHE, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01703013
First received: October 5, 2012
Last updated: October 9, 2012
Last verified: October 2012
  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 Cantonal Hospital of St. Gallen:

Biospecimen Retention:   Samples With DNA

Blood leukocytes, serum


Estimated Enrollment: 75
Study Start Date: January 2013
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Martin BRUTSCHE, Prof., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01703013     History of Changes
Other Study ID Numbers: KSSG-Pneumo-0001
Study First Received: October 5, 2012
Last Updated: October 9, 2012
Health Authority: Switzerland: Ethics Committee of the Canton St. Gallen

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014