Study to Investigate Adrenal Crisis (Six-year Follow-up)

NCT03499990 | Completed

• 1 other identifier: Adrenalcrisis-6FU
• Study Type: observational
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

Conditions

Adrenal Insufficiency

Keywords

Adrenal crisis; Risk factors

Outcome Measures

Primary Outcomes (1)

• Frequency of adrenal crisis

  Evaluation of the frequency of adrenal crisis / number of adrenal crisis per patient years (adrenal crisis/100 patient years). Documentation of the number of adrenal crisis (within a follow-up-period of 6 years) of all participating patients.

  six years

Secondary Outcomes (1)

• Risk factors

  six years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with primary or secondary adrenal insufficiency that already participated in a former prospective study investigating adrenal crisis (Hahner et. al 2015).

You may qualify if:

• Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone)
• Written informed consent

You may not qualify if:

• Adrenal insufficiency due to adrenocortical carcinoma
• Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment
• Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency
• Age younger than 18 years

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Related Publications (4)

• 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, Loeffler M, Bleicken B, Drechsler C, Milovanovic D, Fassnacht M, Ventz M, Quinkler M, Allolio B. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010 Mar;162(3):597-602. doi: 10.1530/EJE-09-0884. Epub 2009 Dec 2.

  PMID: 19955259 BACKGROUND

• Smans LC, Van der Valk ES, Hermus AR, Zelissen PM. Incidence of adrenal crisis in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2016 Jan;84(1):17-22. doi: 10.1111/cen.12865. Epub 2015 Aug 27.

  PMID: 26208266 BACKGROUND

• White K, Arlt W. Adrenal crisis in treated Addison's disease: a predictable but under-managed event. Eur J Endocrinol. 2010 Jan;162(1):115-20. doi: 10.1530/EJE-09-0559. Epub 2009 Sep 23.

  PMID: 19776201 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: April 9, 2018
• First Posted: April 17, 2018
• Study Start: August 13, 2016
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04