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

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ClinicalTrials.gov Identifier: NCT01184209
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):

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

Condition or disease
Adrenal Insufficiency

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.

Study Design

Study Type : Observational
Actual Enrollment : 444 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort-study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency
Study Start Date : February 2007
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. incidence of adrenal crisis [ Time Frame: during study period ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: during study period ]

Other Outcome Measures:
  1. hospital admission [ Time Frame: during study period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients with chronic secondary or primary adrenal failure

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184209

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
Study Chair: Bruno Allolio, MD University of Wuerzburg
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Allolio, MD, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT01184209     History of Changes
Other Study ID Numbers: WueAC17/07
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents