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Completed

NCT Number: NCT03426332

Management of Adrenal Emergency in Germany

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.

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Key information

Conditions

Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 years

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Endocrinology in Charlottenburg, Berlin, Germany
  • University Hospital, Frankfurt, Germany

Registry information

Official study title

Management of Adrenal Emergency in Germany - a Prospective Multicenter

Acronym: MAdEy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2018
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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