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Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

NCT ID: NCT04642391

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-02

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis Adrenal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RAI

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.

Cosyntropin

Intervention Type DRUG

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

Non-RAI

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.

Cosyntropin

Intervention Type DRUG

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

Interventions

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Cosyntropin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Association for the Study of Liver Diseases

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Brian Wentworth, MD

Assistant Professor Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HSR200392

Identifier Type: -

Identifier Source: org_study_id