NCT03410160

Predisposing Factors for the Incidence of Adrenal Crisis

Predisposing Factors for the Incidence of Adrenal Crisis in Chronic Adrenal Insufficiency

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 71 (estimated)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Adrenal Insufficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical and biochemical examination.	Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as 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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-06-01
• Completion: 2019-12-01
• First posted: 2018-01-25
• Last updated: 2019-10-14

Locations

1 site across 1 country: Germany