Management of Adrenal Emergency in Germany (MAdEy)

February 1, 2018 updated by: Wuerzburg University Hospital

Management of Adrenal Emergency in Germany - a Prospective Multicenter

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥18 years with a documented chronic adrenal insufficiency under established corticosteroid replacement therapy.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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