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Management of Adrenal Emergency in Germany

Management of Adrenal Emergency in Germany - a Prospective Multicenter

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03426332
Acronym
MAdEy
Enrollment
150
Registered
2018-02-08
Start date
2015-11-30
Completion date
2017-11-30
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

Keywords

Adrenal Insufficiency, Adrenal crisis, Adrenal emergency, Glucocorticoid injection

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

University Hospital, Frankfurt, Germany
CollaboratorUNKNOWN
Endocrinology in Charlottenburg, Berlin, Germany
CollaboratorUNKNOWN
Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\- Age \<18 years

Design outcomes

Primary

MeasureTime frameDescription
Number of patients that received an intramuscular glucocorticoid-injection6-36 monthsEvaluation 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.
Median time from contacting a medical professional to arrival of professional medical help6-36 monthsEvaluation 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.
Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional6-36 monthsEvaluation 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.
Median time from the beginning of symptoms to glucocorticoid-injection6-36 monthsEvaluation 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.
Duration of hospitalisation (number of days at a hospital)6-36 monthsEvaluation 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.

Secondary

MeasureTime frameDescription
Cause of the adrenal emergency6-36 monthsEvaluation 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.
Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency6-36 monthsEvaluation 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.
Median time from the beginning of symptoms to contacting a medical professional6-36 monthsEvaluation 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.
Symptoms of the adrenal emergency6-36 monthsEvaluation 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.
Median amount of additionally oral ingested glucocorticoids during the adrenal emergency6-36 monthsEvaluation 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026