Management of Adrenal Emergency in Germany

Adrenal Insufficiency Clinical Trial

— MAdEy  

Official title:

Management of Adrenal Emergency in Germany - a Prospective Multicenter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426332
• Other study ID #: MAdEy-Study
• Status: Completed
• Phase: N/A
• First received: January 18, 2018
• Last updated: February 1, 2018
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Documented chronic adrenal insufficiency

• Established corticosteroid replacement therapy

• Written informed consent

Exclusion Criteria:

• Age <18 years

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Emergencies

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Endocrinology in Charlottenburg, Berlin, Germany, University Hospital, Frankfurt, Germany

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time from contacting a medical professional to arrival of professional medical help	Evaluation of the median time (in minutes) from contacting a medical professional (by the patient) to arrival of professional medical help during an (adrenal) emergency.; The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Primary	Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional	Evaluation of the median time (in minutes) from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional.; The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Primary	Median time from the beginning of symptoms to glucocorticoid-injection	Evaluation of the median time (in minutes) from the beginning of symptoms to glucocorticoid-injection during an (adrenal) emergency.; The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Primary	Duration of hospitalisation (number of days at a hospital)	Evaluation of the duration of hospitalisation (number of days at a hospital) due to an adrenal emergency.; The number of days is documented by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Primary	Number of patients that received an intramuscular glucocorticoid-injection	Evaluation of the number of patients that received an intramuscular glucocorticoid-injection (compared to subcutaneous administration) during an adrenal emergency. Documentation by the patients themselves directly after the adrenal emergency.	6-36 months
Secondary	Cause of the adrenal emergency	Evaluation of the causes of the adrenal emergencies. The causes are documented in a questionnaire by the patients themselves. The number of different causes that are stated by all patients will be evaluated.	6-36 months
Secondary	Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency	Evaluation of the median time (in minutes) from the beginning of symptoms to oral dose adjustment (glucocorticoids).; The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Secondary	Median time from the beginning of symptoms to contacting a medical professional	Evaluation of the median time (in minutes) from the beginning of symptoms to contacting a medical professional during an adrenal emergency.; The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months
Secondary	Symptoms of the adrenal emergency	Evaluation of the symptoms during the adrenal emergencies. The symptoms are documented in a questionnaire by the patients themselves. The number of different symptoms that are stated by all patients will be evaluated.	6-36 months
Secondary	Median amount of additionally oral ingested glucocorticoids during the adrenal emergency	Evaluation of the median amount of additionally oral ingested glucocorticoids (in mg) during the adrenal emergency.; The amount of glucocorticoids is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.	6-36 months