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Study to Investigate Adrenal Crisis (Six-year Follow-up)

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. Identifier: NCT03499990
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Wuerzburg University Hospital

Brief Summary:
Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

Condition or disease
Adrenal Insufficiency

Detailed Description:
Despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. A former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. The aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. Patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).

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Study Type : Observational
Actual Enrollment : 268 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)
Actual Study Start Date : August 13, 2016
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017

Primary Outcome Measures :
  1. Frequency of adrenal crisis [ Time Frame: six years ]
    Evaluation of the frequency of adrenal crisis / number of adrenal crisis per patient years (adrenal crisis/100 patient years). Documentation of the number of adrenal crisis (within a follow-up-period of 6 years) of all participating patients.

Secondary Outcome Measures :
  1. Risk factors [ Time Frame: six years ]
    Identification of risk factors / confirmation of risk factors observed in former trials (previous adrenal crisis, female sex, diabetes insipidus) for adrenal crisis. Calculation of odds ratios.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients with primary or secondary adrenal insufficiency that already participated in a former prospective study investigating adrenal crisis (Hahner et. al 2015).

Inclusion Criteria:

  • Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone)
  • Written informed consent

Exclusion Criteria:

  • Adrenal insufficiency due to adrenocortical carcinoma
  • Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment
  • Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency
  • Age younger than 18 years

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Responsible Party: Wuerzburg University Hospital Identifier: NCT03499990    
Other Study ID Numbers: Adrenalcrisis-6FU
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuerzburg University Hospital:
Adrenal crisis
Risk factors
Additional relevant MeSH terms:
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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