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
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.

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 August 01, 2014