NCT04642391

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

Defining the Mechanisms Underlying Adrenal Dysfunction in Cirrhosis and Its Prognostic Significance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study aims to define the prevalence and potential pathophysiologic mechanisms underlying relative adrenal insufficiency (RAI) in outpatients with decompensated cirrhosis. Patients will be followed prospectively for up to two years to determine incidence of RAI, whether RAI represents a permanent or dynamic physiologic state in cirrhosis, and to determine whether RAI in this setting is associated with important clinical outcomes.

Conditions

• Cirrhosis
• Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Cosyntropin	Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis

Timeline

• Start date: 2021-08-02
• Primary completion: 2023-06-30
• Completion: 2024-06-30
• First posted: 2020-11-24
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study