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Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University of Wuerzburg.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01184209
First received: August 17, 2010
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.


Condition
Adrenal Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort-study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Addison Disease
U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Estimated Enrollment: 500
Study Start Date: February 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective study following patients with chronic adrenal insufficiency by contacting them every 6 months via questionnaires and telephone. QUestionnaires assess incidence and causes of adrenal crisis, frequency of hospitalization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients with chronic secondary or primary adrenal failure

Criteria

Inclusion Criteria:

  • chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy

Exclusion Criteria:

  • adrenocortical carcinoma
  • long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency
  • age < 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184209

Contacts
Contact: Stefanie Hahner, MD 0049 931 201 36508 hahner_s@medizin.uni-wuerzburg.de
Contact: Bruno Allolio, MD 0049 931 201 36109 allolio_b@medizin.uni-wuerzburg.de

Locations
Germany
University of Berlin Recruiting
Berlin, Germany, D-10117
Contact: Marcus Quinkler, MD     0049 30 450514259     m.quinkler@charite.de    
Principal Investigator: Marcus Quinkler, MD            
University of Wuerzburg Recruiting
Wuerzburg, Germany, D-97080
Contact: Stefanie Hahner, MD     0049 931 201 36508     hahner_s@medizin.uni-wuerzburg.de    
Principal Investigator: Stefanie Hahner, MD            
Sponsors and Collaborators
University of Wuerzburg
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Investigators
Study Chair: Bruno Allolio, MD University of Wuerzburg
  More Information

No publications provided

Responsible Party: prospective trial on incidence and causes of adrenal crisis, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT01184209     History of Changes
Other Study ID Numbers: WueAC17/07
Study First Received: August 17, 2010
Last Updated: August 17, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013