Management of Adrenal Emergency in Germany

Completed

• Conditions: Adrenal Insufficiency

• Registration Number: NCT03426332
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Study First Submitted: 2018-01-18
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-01
• Last Update Submitted: 2018-02-01
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• Age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional	6-36 months	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.
Median time from the beginning of symptoms to glucocorticoid-injection	6-36 months	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.
Duration of hospitalisation (number of days at a hospital)	6-36 months	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.
Median time from contacting a medical professional to arrival of professional medical help	6-36 months	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.
Number of patients that received an intramuscular glucocorticoid-injection	6-36 months	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.

Secondary Outcome Measures

Name	Time	Method
Cause of the adrenal emergency	6-36 months	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.
Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency	6-36 months	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.
Median time from the beginning of symptoms to contacting a medical professional	6-36 months	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.
Symptoms of the adrenal emergency	6-36 months	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.
Median amount of additionally oral ingested glucocorticoids during the adrenal emergency	6-36 months	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.