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

Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03499990

Enrollment

268

Registered

2018-04-17

Start date

2016-08-13

Completion date

2017-05-23

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

Keywords

Adrenal crisis, Risk factors

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results