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

Adrenal Insufficiency Clinical Trial

Official title:

Prospective Cohort-study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184209
• Other study ID #: WueAC17/07
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: January 3, 2014
• Start date: February 2007
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Insufficiency

Locations

Country	Name	City	State
Germany	University of Berlin	Berlin
Germany	University of Wuerzburg	Wuerzburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Wuerzburg	Charite University, Berlin, Germany, Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hospital admission		during study period	No
Primary	incidence of adrenal crisis		during study period	No
Secondary	mortality		during study period	No