Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

Defining the Incidence of and Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

Sponsors

Lead Sponsor: University of Virginia

Source University of Virginia
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.

Overall Status Not yet recruiting
Start Date 2021-07-01
Completion Date 2023-12-30
Primary Completion Date 2022-12-30
Study Type Observational
Primary Outcome
Measure Time Frame
RAI prevalence 1 year
Baseline Cholesterol Esterification Percentage baseline
6 month Cholesterol Esterification Percentage 6 months
12 month Cholesterol Esterification Percentage 12 months
18 month Cholesterol Esterification Percentage 18 months
24 month Cholesterol Esterification Percentage 24 months
Baseline 17-OH Progesterone Level baseline
6 month 17-OH Progesterone Level 6 month
12 month 17-OH Progesterone Level 12 months
18 month 17-OH Progesterone Level 18 months
24 month 17-OH Progesterone Level 24 months
Baseline ACTH level baseline
6 month ACTH level 6 months
12 month ACTH level 12 months
18 month ACTH level 18 months
24 month ACTH level 24 months
Baseline IL-1 Level baseline
6 month IL-1 Level 6 months
12 month IL-1 Level 12 months
18 month IL-1 Level 18 months
24 month IL-1 Level 24 months
Baseline Plasma Renin Activity baseline
6 month Plasma Renin Activity 6 month
12 month Plasma Renin Activity 12 month
18 month Plasma Renin Activity 18 month
24 month Plasma Renin Activity 24 month
Baseline serum normetanephrine level baseline
6 month serum normetanephrine level 6 month
12 month serum normetanephrine level 12 month
18 month serum normetanephrine level 18 month
24 month serum normetanephrine level 24 month
Baseline 11-deoxycortisol level baseline
6 month 11-deoxycortisol level 6 months
12 month 11-deoxycortisol level 12 months
18 month 11-deoxycortisol level 18 months
24 month 11-deoxycortisol level 24 months
Baseline HDL level baseline
6 month HDL level 6 months
12 month HDL level 12 months
18 month HDL level 18 months
24 month HDL level 24 months
Baseline IL-6 level baseline
6 month IL-6 level 6 months
12 month IL-6 level 12 months
18 month IL-6 level 18 months
24 month IL-6 level 24 months
Baseline IL-10 level baseline
6 month IL-10 level 6 months
12 month IL-10 level 12 months
18 month IL-10 level 18 months
24 month IL-10 level 24 months
Baseline TNFa level baseline
6 month TNFa level 6 months
12 month TNFa level 12 months
18 month TNFa level 18 months
24 month TNFa level 24 months
Secondary Outcome
Measure Time Frame
Annualized Incidence of RAI over two years
30-day transplant-free survival 30 days
90-day transplant-free survival 90 days
6-month transplant-free survival 6 months
1 year transplant-free survival 1 year
2 year transplant-free survival 2 years
30 day new or worsened portal hypertensive decompensation 30 days
90 day new or worsened portal hypertensive decompensation 90 days
6 month new or worsened portal hypertensive decompensation 6 months
1 year new or worsened portal hypertensive decompensation 1 year
2 year new or worsened portal hypertensive decompensation 2 years
30 day unplanned hospitalization 30 days
90 day unplanned hospitalization 90 days
6 month unplanned hospitalization 6 month
1 year unplanned hospitalization 1 year
2 year unplanned hospitalization 2 year
Enrollment 135
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cosyntropin

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

Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

100 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Brian J Wentworth, MD

Phone: 4342432109

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: University of Virginia Health System Brian J Wentworth, MD 434-243-2109 [email protected] Helmy Siragy, MD Sub-Investigator Stephen Caldwell, MD Sub-Investigator Curtis Argo, MD Sub-Investigator
Location Countries

United States

Verification Date

2020-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Virginia

Investigator Full Name: Brian Wentworth, MD

Investigator Title: Transplant Hepatology Fellow

Has Expanded Access No
Condition Browse
Arm Group

Label: RAI

Description: 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.

Label: Non-RAI

Description: 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.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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