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

This study has been completed.
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Bruno Allolio, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01184209
First received: August 17, 2010
Last updated: January 3, 2014
Last verified: January 2014
  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:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • incidence of adrenal crisis [ Time Frame: during study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: during study period ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • hospital admission [ Time Frame: during study period ] [ Designated as safety issue: No ]

Enrollment: 444
Study Start Date: February 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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

Locations
Germany
University of Berlin
Berlin, Germany, D-10117
University of Wuerzburg
Wuerzburg, Germany, D-97080
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: Bruno Allolio, MD, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT01184209     History of Changes
Other Study ID Numbers: WueAC17/07
Study First Received: August 17, 2010
Last Updated: January 3, 2014
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 April 20, 2014