Predisposing Factors for the Incidence of Adrenal Crisis (PIA)

Wuerzburg University Hospital

Status: Unknown

Conditions: Adrenal Insufficiency

Treatments: Diagnostic Test: Clinical and biochemical examination.

Study type: Observational

Funder types: Other

Identifiers

NCT03410160

PIA

Details and patient eligibility

About

Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.

Full description

Patients with chronic adrenal insufficiency (AI) are at risk of suffering from life-threatening adrenal crisis (AC), despite established hormone replacement therapies and patient education. Recent retrospective analyses observed different risk factors for AC, e.g. primary AI and comorbidities. Furthermore, patients that already experienced an AC seem to have an increased risk to develop further AC. The aim of the study is to evaluate potential risk factors/predisposing factors for AC in patients with chronic primary and secondary AI (PAI/SAI). Patients with chronic AI are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. AI patients with a high frequency of AC will be compared to matched controls (age, sex and cause of AI) with no AC or a low frequency of AC in the past.

Enrollment: 71 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Patient´s written informed consent
• Ability to comply with the protocol procedures
• Patients with chronic primary or secondary adrenal insufficiency under established stable replacement therapy (disease duration at least 2 years)

Exclusion criteria

• Age <18 years
• Pregnancy or breast feeding
• Intake of CYP3A4-inducting-drugs

Trial design

71 participants in 2 patient groups

High frequency of adrenal crisis

Description:

Patients with a high frequency of adrenal crisis in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).

Treatment:

Diagnostic Test: Clinical and biochemical examination.

Low frequency of adrenal crisis

Description:

Patients with no adrenal crisis or a low frequency of AC in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).

Treatment:

Diagnostic Test: Clinical and biochemical examination.