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

Wuerzburg University Hospital

Status: Completed

Conditions: Adrenal Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT03499990

Adrenalcrisis-6FU

Details and patient eligibility

About

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).

Full 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).

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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