Clinical trial NCT03426332: Management of Adrenal Emergency in Germany
Official title: Management of Adrenal Emergency in Germany - a Prospective Multicenter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Keywords: Adrenal Insufficiency
Adrenal crisis
Adrenal emergency
Glucocorticoid injection
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Frankfurt, Germany
name: Endocrinology in Charlottenburg, Berlin, Germany
First posted: 2018-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥18 years with a documented chronic adrenal insufficiency under established corticosteroid replacement therapy.

Brief summary: The management of adrenal crisis is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients with chronic adrenal insufficiency.

Detailed description: Despite established hormone replacement therapy, patients with chronic adrenal insufficiency (AI) are at risk of suffering from adrenal crisis (AC). Further data suggests that the management of AC is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies (AE) requiring parenteral glucocorticoid (GC) treatment by a prospective multicenter study.

Patients with chronic AI receive a questionnaire on the management of emergency situations, which had to be completed and sent back in case of an emergency requiring parenteral GC administration. Furthermore, patients were contacted by phone in case of a missing response every six months.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Documented chronic adrenal insufficiency
* Established corticosteroid replacement therapy
* Written informed consent

Exclusion Criteria:

- Age \<18 years

Primary outcomes:
measure: Median time from contacting a medical professional to arrival of professional medical help
timeFrame: 6-36 months
measure: Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional
timeFrame: 6-36 months
measure: Median time from the beginning of symptoms to glucocorticoid-injection
timeFrame: 6-36 months
measure: Duration of hospitalisation (number of days at a hospital)
timeFrame: 6-36 months
measure: Number of patients that received an intramuscular glucocorticoid-injection
timeFrame: 6-36 months
Secondary outcomes:
measure: Cause of the adrenal emergency
timeFrame: 6-36 months
measure: Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency
timeFrame: 6-36 months
measure: Median time from the beginning of symptoms to contacting a medical professional
timeFrame: 6-36 months
measure: Symptoms of the adrenal emergency
timeFrame: 6-36 months
measure: Median amount of additionally oral ingested glucocorticoids during the adrenal emergency
timeFrame: 6-36 months
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, Hemmelmann N, Quinkler M, Beuschlein F, Spinnler C, Allolio B. Timelines in the management of adrenal crisis - targets, limits and reality. Clin Endocrinol (Oxf). 2015 Apr;82(4):497-502. doi: 10.1111/cen.12609. Epub 2014 Nov 6.
citation: Allolio B. Extensive expertise in endocrinology. Adrenal crisis. Eur J Endocrinol. 2015 Mar;172(3):R115-24. doi: 10.1530/EJE-14-0824. Epub 2014 Oct 6.