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

Completed

• Conditions: Adrenal Insufficiency

• Registration Number: NCT03499990
• Lead Sponsor: Wuerzburg University Hospital

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).

Detailed Description

Despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. A former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. The aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. Patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).

Study Timeline

• Study Start: 2016-08-13
• Primary Completion: 2017-05-23
• Study Completion: 2017-05-23
• Status Verified: 2018-04
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of adrenal crisis	six years	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.

Secondary Outcome Measures

Name	Time	Method
Risk factors	six years	Identification of risk factors / confirmation of risk factors observed in former trials (previous adrenal crisis, female sex, diabetes insipidus) for adrenal crisis. Calculation of odds ratios.