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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Frankfurt, Germany
Endocrinology in Charlottenburg, Berlin, Germany

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAdEy-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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