Management of Adrenal Emergency in Germany

NCT03426332 | Completed

• 1 other identifier: MAdEy-Study
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adrenal Insufficiency

Keywords

Adrenal Insufficiency; Adrenal crisis; Adrenal emergency; Glucocorticoid injection

Outcome Measures

Primary Outcomes (5)

• Median time from contacting a medical professional to arrival of professional medical help

  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

  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

  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)

  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

  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 Outcomes (5)

• Cause of the adrenal emergency

  6-36 months

• Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency

  6-36 months

• Median time from the beginning of symptoms to contacting a medical professional

  6-36 months

• Symptoms of the adrenal emergency

  6-36 months

• Median amount of additionally oral ingested glucocorticoids during the adrenal emergency

  6-36 months

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- Age \<18 years

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University Hospital, Frankfurt, Germany: collaborator
• Endocrinology in Charlottenburg, Berlin, Germany: collaborator

Related Publications (3)

• 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.

  PMID: 25419882 BACKGROUND

• 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.

  PMID: 25200922 BACKGROUND

• 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.

  PMID: 25288693 BACKGROUND

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 8, 2018
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02