CompletedNot Applicable

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

United States76 participantsStarted 2021-08-02

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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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

What they're measuring

RAI prevalence

Timeframe: 1 year

Baseline Cholesterol Esterification Percentage

Timeframe: baseline

6 month Cholesterol Esterification Percentage

Timeframe: 6 months

12 month Cholesterol Esterification Percentage

Timeframe: 12 months

18 month Cholesterol Esterification Percentage

Timeframe: 18 months

24 month Cholesterol Esterification Percentage

Timeframe: 24 months

Baseline 17-OH Progesterone Level

Timeframe: baseline

6 month 17-OH Progesterone Level

Timeframe: 6 month

12 month 17-OH Progesterone Level

Trial details

NCT IDNCT04642391

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

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