Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

University of Virginia76 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cirrhosis Adrenal Insufficiency

Interventions

CosyntropinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia Health System

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

RAI prevalence

Time frame: 1 year

Baseline Cholesterol Esterification Percentage

Time frame: baseline

6 month Cholesterol Esterification Percentage

Time frame: 6 months

12 month Cholesterol Esterification Percentage

Time frame: 12 months

18 month Cholesterol Esterification Percentage

Time frame: 18 months

24 month Cholesterol Esterification Percentage

Time frame: 24 months

Baseline 17-OH Progesterone Level

Time frame: baseline

6 month 17-OH Progesterone Level

Time frame: 6 month

12 month 17-OH Progesterone Level

Time frame: 12 months

18 month 17-OH Progesterone Level

Time frame: 18 months

24 month 17-OH Progesterone Level

Time frame: 24 months

Baseline ACTH level

Time frame: baseline

6 month ACTH level

Time frame: 6 months

Data from ClinicalTrials.gov

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Time frame: 12 months

18 month ACTH level

Time frame: 18 months

24 month ACTH level

Time frame: 24 months

Baseline IL-1 Level

Time frame: baseline

6 month IL-1 Level

Time frame: 6 months

12 month IL-1 Level

Time frame: 12 months

18 month IL-1 Level

Time frame: 18 months

24 month IL-1 Level

Time frame: 24 months

Baseline Plasma Renin Activity

Time frame: baseline

6 month Plasma Renin Activity

Time frame: 6 month

12 month Plasma Renin Activity

Time frame: 12 month

18 month Plasma Renin Activity

Time frame: 18 month

24 month Plasma Renin Activity

Time frame: 24 month

Baseline serum normetanephrine level

Time frame: baseline

6 month serum normetanephrine level

Time frame: 6 month

12 month serum normetanephrine level

Time frame: 12 month

18 month serum normetanephrine level

Time frame: 18 month

24 month serum normetanephrine level

Time frame: 24 month

Baseline 11-deoxycortisol level

Time frame: baseline

6 month 11-deoxycortisol level

Time frame: 6 months

12 month 11-deoxycortisol level

Time frame: 12 months

18 month 11-deoxycortisol level

Time frame: 18 months

24 month 11-deoxycortisol level

Time frame: 24 months

Baseline HDL level

Time frame: baseline

6 month HDL level

Time frame: 6 months

12 month HDL level

Time frame: 12 months

18 month HDL level

Time frame: 18 months

24 month HDL level

Time frame: 24 months

Baseline IL-6 level

Time frame: baseline

6 month IL-6 level

Time frame: 6 months

12 month IL-6 level

Time frame: 12 months

18 month IL-6 level

Time frame: 18 months

24 month IL-6 level

Time frame: 24 months

Baseline IL-10 level

Time frame: baseline

6 month IL-10 level

Time frame: 6 months

12 month IL-10 level

Time frame: 12 months

18 month IL-10 level

Time frame: 18 months

24 month IL-10 level

Time frame: 24 months

Baseline TNFa level

Time frame: baseline

6 month TNFa level

Time frame: 6 months

12 month TNFa level

Time frame: 12 months

18 month TNFa level

Time frame: 18 months

24 month TNFa level

Time frame: 24 months

Secondary Outcomes

Annualized Incidence of RAI

Time frame: over two years

30-day transplant-free survival

Time frame: 30 days

90-day transplant-free survival

Time frame: 90 days

6-month transplant-free survival

Time frame: 6 months

1 year transplant-free survival

Time frame: 1 year

2 year transplant-free survival

Time frame: 2 years

30 day new or worsened portal hypertensive decompensation

Time frame: 30 days

90 day new or worsened portal hypertensive decompensation

Time frame: 90 days

6 month new or worsened portal hypertensive decompensation

Time frame: 6 months

1 year new or worsened portal hypertensive decompensation

Time frame: 1 year

2 year new or worsened portal hypertensive decompensation

Time frame: 2 years

30 day unplanned hospitalization

Time frame: 30 days

90 day unplanned hospitalization

Time frame: 90 days

6 month unplanned hospitalization

Time frame: 6 month

1 year unplanned hospitalization

Time frame: 1 year

2 year unplanned hospitalization

Time frame: 2 year