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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184209
First Posted: August 18, 2010
Last Update Posted: January 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ludwig-Maximilians - University of Munich
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Bruno Allolio, University of Wuerzburg
  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 Bruno Allolio, University of Wuerzburg:

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

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

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

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

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
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
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


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

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 Submitted: August 17, 2010
First Posted: August 18, 2010
Last Update Posted: January 6, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents