Clinical trial NCT03499990: Study to Investigate Adrenal Crisis (Six-year Follow-up)
Official title: Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Keywords: Adrenal crisis
Risk factors
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of adrenal crisis
timeFrame: six years
Secondary outcomes:
measure: Risk factors
timeFrame: six years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.