Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04642391
• Other study ID #: HSR200392
• Status: Active, not recruiting
• Start date: August 2, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	American Association for the Study of Liver Diseases

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RAI prevalence		1 year
Primary	Baseline Cholesterol Esterification Percentage		baseline
Primary	6 month Cholesterol Esterification Percentage		6 months
Primary	12 month Cholesterol Esterification Percentage		12 months
Primary	18 month Cholesterol Esterification Percentage		18 months
Primary	24 month Cholesterol Esterification Percentage		24 months
Primary	Baseline 17-OH Progesterone Level		baseline
Primary	6 month 17-OH Progesterone Level		6 month
Primary	12 month 17-OH Progesterone Level		12 months
Primary	18 month 17-OH Progesterone Level		18 months
Primary	24 month 17-OH Progesterone Level		24 months
Primary	Baseline ACTH level		baseline
Primary	6 month ACTH level		6 months
Primary	12 month ACTH level		12 months
Primary	18 month ACTH level		18 months
Primary	24 month ACTH level		24 months
Primary	Baseline IL-1 Level		baseline
Primary	6 month IL-1 Level		6 months
Primary	12 month IL-1 Level		12 months
Primary	18 month IL-1 Level		18 months
Primary	24 month IL-1 Level		24 months
Primary	Baseline Plasma Renin Activity		baseline
Primary	6 month Plasma Renin Activity		6 month
Primary	12 month Plasma Renin Activity		12 month
Primary	18 month Plasma Renin Activity		18 month
Primary	24 month Plasma Renin Activity		24 month
Primary	Baseline serum normetanephrine level		baseline
Primary	6 month serum normetanephrine level		6 month
Primary	12 month serum normetanephrine level		12 month
Primary	18 month serum normetanephrine level		18 month
Primary	24 month serum normetanephrine level		24 month
Primary	Baseline 11-deoxycortisol level		baseline
Primary	6 month 11-deoxycortisol level		6 months
Primary	12 month 11-deoxycortisol level		12 months
Primary	18 month 11-deoxycortisol level		18 months
Primary	24 month 11-deoxycortisol level		24 months
Primary	Baseline HDL level		baseline
Primary	6 month HDL level		6 months
Primary	12 month HDL level		12 months
Primary	18 month HDL level		18 months
Primary	24 month HDL level		24 months
Primary	Baseline IL-6 level		baseline
Primary	6 month IL-6 level		6 months
Primary	12 month IL-6 level		12 months
Primary	18 month IL-6 level		18 months
Primary	24 month IL-6 level		24 months
Primary	Baseline IL-10 level		baseline
Primary	6 month IL-10 level		6 months
Primary	12 month IL-10 level		12 months
Primary	18 month IL-10 level		18 months
Primary	24 month IL-10 level		24 months
Primary	Baseline TNFa level		baseline
Primary	6 month TNFa level		6 months
Primary	12 month TNFa level		12 months
Primary	18 month TNFa level		18 months
Primary	24 month TNFa level		24 months
Secondary	Annualized Incidence of RAI		over two years
Secondary	30-day transplant-free survival		30 days
Secondary	90-day transplant-free survival		90 days
Secondary	6-month transplant-free survival		6 months
Secondary	1 year transplant-free survival		1 year
Secondary	2 year transplant-free survival		2 years
Secondary	30 day new or worsened portal hypertensive decompensation		30 days
Secondary	90 day new or worsened portal hypertensive decompensation		90 days
Secondary	6 month new or worsened portal hypertensive decompensation		6 months
Secondary	1 year new or worsened portal hypertensive decompensation		1 year
Secondary	2 year new or worsened portal hypertensive decompensation		2 years
Secondary	30 day unplanned hospitalization		30 days
Secondary	90 day unplanned hospitalization		90 days
Secondary	6 month unplanned hospitalization		6 month
Secondary	1 year unplanned hospitalization		1 year
Secondary	2 year unplanned hospitalization		2 year