Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
- Registration Number
- NCT04642391
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RAI Cosyntropin 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. Non-RAI Cosyntropin 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.
- Primary Outcome Measures
Name Time Method Baseline IL-6 level baseline Baseline TNFa level baseline 18 month ACTH level 18 months 6 month IL-6 level 6 months 12 month IL-6 level 12 months 24 month IL-10 level 24 months 6 month TNFa level 6 months 18 month TNFa level 18 months 18 month serum normetanephrine level 18 month 24 month serum normetanephrine level 24 month 6 month ACTH level 6 months RAI prevalence 1 year 12 month Cholesterol Esterification Percentage 12 months Baseline Cholesterol Esterification Percentage baseline 6 month Cholesterol Esterification Percentage 6 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 12 month ACTH level 12 months 24 month ACTH level 24 months Baseline IL-1 Level baseline 6 month IL-1 Level 6 months 12 month Plasma Renin Activity 12 month 18 month 17-OH Progesterone Level 18 months 24 month 17-OH Progesterone Level 24 months Baseline ACTH level baseline 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 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 Baseline 11-deoxycortisol level baseline 6 month 11-deoxycortisol level 6 months 12 month 11-deoxycortisol level 12 months 24 month 11-deoxycortisol level 24 months 24 month IL-6 level 24 months Baseline IL-10 level baseline 18 month 11-deoxycortisol level 18 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 18 month IL-6 level 18 months 6 month IL-10 level 6 months 12 month IL-10 level 12 months 18 month IL-10 level 18 months 12 month TNFa level 12 months 24 month TNFa level 24 months
- Secondary Outcome Measures
Name Time Method 90 day new or worsened portal hypertensive decompensation 90 days 6 month new or worsened portal hypertensive decompensation 6 months Annualized Incidence of RAI over two years 30-day transplant-free survival 30 days 90-day transplant-free survival 90 days 1 year transplant-free survival 1 year 2 year transplant-free survival 2 years 30 day new or worsened portal hypertensive decompensation 30 days 6-month transplant-free survival 6 months 1 year new or worsened portal hypertensive decompensation 1 year 2 year new or worsened portal hypertensive decompensation 2 years 1 year unplanned hospitalization 1 year 30 day unplanned hospitalization 30 days 90 day unplanned hospitalization 90 days 6 month unplanned hospitalization 6 month 2 year unplanned hospitalization 2 year
Trial Locations
- Locations (1)
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States