- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426332
Management of Adrenal Emergency in Germany (MAdEy)
Management of Adrenal Emergency in Germany - a Prospective Multicenter
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Documented chronic adrenal insufficiency
- Established corticosteroid replacement therapy
- Written informed consent
Exclusion Criteria:
- Age <18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median time from contacting a medical professional to arrival of professional medical help
Time Frame: 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. |
6-36 months
|
Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional
Time Frame: 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. |
6-36 months
|
Median time from the beginning of symptoms to glucocorticoid-injection
Time Frame: 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. |
6-36 months
|
Duration of hospitalisation (number of days at a hospital)
Time Frame: 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. |
6-36 months
|
Number of patients that received an intramuscular glucocorticoid-injection
Time Frame: 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.
|
6-36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cause of the adrenal emergency
Time Frame: 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.
|
6-36 months
|
Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency
Time Frame: 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. |
6-36 months
|
Median time from the beginning of symptoms to contacting a medical professional
Time Frame: 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. |
6-36 months
|
Symptoms of the adrenal emergency
Time Frame: 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.
|
6-36 months
|
Median amount of additionally oral ingested glucocorticoids during the adrenal emergency
Time Frame: 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. |
6-36 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAdEy-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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