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Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04642391
Enrollment
76
Registered
2020-11-24
Start date
2021-08-02
Completion date
2024-06-30
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Adrenal Insufficiency

Brief 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.

Interventions

DRUGCosyntropin

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

Sponsors

American Association for the Study of Liver Diseases
CollaboratorOTHER
University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
18 month IL-10 level18 months
Baseline TNFa levelbaseline
6 month TNFa level6 months
12 month TNFa level12 months
18 month TNFa level18 months
24 month TNFa level24 months
18 month 11-deoxycortisol level18 months
24 month 11-deoxycortisol level24 months
Baseline HDL levelbaseline
6 month HDL level6 months
12 month HDL level12 months
18 month HDL level18 months
24 month HDL level24 months
Baseline IL-6 levelbaseline
6 month IL-6 level6 months
12 month IL-6 level12 months
18 month IL-6 level18 months
24 month IL-6 level24 months
Baseline IL-10 levelbaseline
6 month IL-10 level6 months
12 month IL-10 level12 months
24 month IL-10 level24 months
RAI prevalence1 year
Baseline Cholesterol Esterification Percentagebaseline
6 month Cholesterol Esterification Percentage6 months
12 month Cholesterol Esterification Percentage12 months
18 month Cholesterol Esterification Percentage18 months
24 month Cholesterol Esterification Percentage24 months
Baseline 17-OH Progesterone Levelbaseline
6 month 17-OH Progesterone Level6 month
12 month 17-OH Progesterone Level12 months
18 month 17-OH Progesterone Level18 months
24 month 17-OH Progesterone Level24 months
Baseline ACTH levelbaseline
6 month ACTH level6 months
12 month ACTH level12 months
18 month ACTH level18 months
24 month ACTH level24 months
Baseline IL-1 Levelbaseline
6 month IL-1 Level6 months
12 month IL-1 Level12 months
18 month IL-1 Level18 months
24 month IL-1 Level24 months
Baseline Plasma Renin Activitybaseline
6 month Plasma Renin Activity6 month
12 month Plasma Renin Activity12 month
18 month Plasma Renin Activity18 month
24 month Plasma Renin Activity24 month
Baseline serum normetanephrine levelbaseline
6 month serum normetanephrine level6 month
12 month serum normetanephrine level12 month
18 month serum normetanephrine level18 month
24 month serum normetanephrine level24 month
Baseline 11-deoxycortisol levelbaseline
6 month 11-deoxycortisol level6 months
12 month 11-deoxycortisol level12 months

Secondary

MeasureTime frame
Annualized Incidence of RAIover two years
30-day transplant-free survival30 days
90-day transplant-free survival90 days
6-month transplant-free survival6 months
1 year transplant-free survival1 year
2 year transplant-free survival2 years
30 day new or worsened portal hypertensive decompensation30 days
90 day new or worsened portal hypertensive decompensation90 days
6 month new or worsened portal hypertensive decompensation6 months
1 year new or worsened portal hypertensive decompensation1 year
2 year new or worsened portal hypertensive decompensation2 years
30 day unplanned hospitalization30 days
90 day unplanned hospitalization90 days
6 month unplanned hospitalization6 month
1 year unplanned hospitalization1 year
2 year unplanned hospitalization2 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026