Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

University of Virginia

Status: Completed

Conditions: Adrenal Insufficiency; Cirrhosis

Treatments: Drug: Cosyntropin

Study type: Observational

Funder types: Other

Identifiers

NCT04642391

HSR200392

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 18y
• Diagnosis of cirrhosis by biopsy or compatible clinical picture
• Experienced at least one portal decompensating event in the past and currently have a Child-Pugh B or C classification

Exclusion criteria

• Pregnant women
• Prisoners
• Not been treated with medication known to affect the adrenal axis within the past 4 weeks (oral or IV steroids, ketoconazole, etomidate)
• Hospitalized at time of enrollment

Trial design

76 participants in 2 patient groups

RAI

Description:

Subjects will be diagnosed with relative adrenal insufficiency as determined by administration of a standard-dose ACTH stimulation test (0.25mg Cosyntropin) and an increase in serum total cortisol \<9mcg/dL.

Treatment:

Drug: Cosyntropin

Non-RAI

Description:

Subjects will have not have relative adrenal insufficiency as determined by administration of a standard-dose ACTH stimulation test (0.25mg Cosyntropin) and an increase in serum total cortisol \>= 9mcg/dL.

Treatment:

Drug: Cosyntropin