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CompletedNCT03499990Updated Apr 18, 2018

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

An observational study in Adrenal Insufficiency, sponsored by Wuerzburg University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Wuerzburg University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
268
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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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Conditions studied

  • Adrenal Insufficiency

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Keywords

  • Adrenal crisis
  • Risk factors
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
268 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Frequency of adrenal crisis

    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.

    Time frame: six years

Secondary outcomes

  1. Risk factors

    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.

    Time frame: six years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24. PubMed 25419882 ↗
  • Hahner S, Loeffler M, Bleicken B, Drechsler C, Milovanovic D, Fassnacht M, Ventz M, Quinkler M, Allolio B. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010 Mar;162(3):597-602. doi: 10.1530/EJE-09-0884. Epub 2009 Dec 2. PubMed 19955259 ↗
  • Smans LC, Van der Valk ES, Hermus AR, Zelissen PM. Incidence of adrenal crisis in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2016 Jan;84(1):17-22. doi: 10.1111/cen.12865. Epub 2015 Aug 27. PubMed 26208266 ↗
  • White K, Arlt W. Adrenal crisis in treated Addison's disease: a predictable but under-managed event. Eur J Endocrinol. 2010 Jan;162(1):115-20. doi: 10.1530/EJE-09-0559. Epub 2009 Sep 23. PubMed 19776201 ↗
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Registry details

Key details

Study ID
NCT03499990
Lead sponsor
Wuerzburg University Hospital
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Aug 13, 2016
Primary completion
May 23, 2017
Completion
May 23, 2017
Last update
Apr 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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