- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04642391
Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
December 10, 2023 updated by: Brian Wentworth, MD, University of Virginia
Defining the Mechanisms Underlying Adrenal Dysfunction in Cirrhosis and Its Prognostic Significance
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brian J Wentworth, MD
- Phone Number: 4342432109
- Email: bw8xz@hscmail.mcc.virginia.edu
Study Locations
-
-
Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Health System
-
Contact:
- Brian J Wentworth, MD
- Phone Number: 434-243-2109
- Email: bw8xz@hscmail.mcc.virginia.edu
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Contact:
- Zachary H Henry, MD
- Phone Number: 434-243-2718
- Email: zhh6z@virginia.edu
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Sub-Investigator:
- Helmy Siragy, MD
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Sub-Investigator:
- Stephen Caldwell, MD
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Sub-Investigator:
- Curtis Argo, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Decompensated cirrhosis (cirrhosis + at least 1 clinically-significant decompensation including ascites/hepatic hydrothorax, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RAI
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.
|
Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis
|
Non-RAI
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.
|
Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
RAI prevalence
Time Frame: 1 year
|
1 year
|
Baseline Cholesterol Esterification Percentage
Time Frame: baseline
|
baseline
|
6 month Cholesterol Esterification Percentage
Time Frame: 6 months
|
6 months
|
12 month Cholesterol Esterification Percentage
Time Frame: 12 months
|
12 months
|
18 month Cholesterol Esterification Percentage
Time Frame: 18 months
|
18 months
|
24 month Cholesterol Esterification Percentage
Time Frame: 24 months
|
24 months
|
Baseline 17-OH Progesterone Level
Time Frame: baseline
|
baseline
|
6 month 17-OH Progesterone Level
Time Frame: 6 month
|
6 month
|
12 month 17-OH Progesterone Level
Time Frame: 12 months
|
12 months
|
18 month 17-OH Progesterone Level
Time Frame: 18 months
|
18 months
|
24 month 17-OH Progesterone Level
Time Frame: 24 months
|
24 months
|
Baseline ACTH level
Time Frame: baseline
|
baseline
|
6 month ACTH level
Time Frame: 6 months
|
6 months
|
12 month ACTH level
Time Frame: 12 months
|
12 months
|
18 month ACTH level
Time Frame: 18 months
|
18 months
|
24 month ACTH level
Time Frame: 24 months
|
24 months
|
Baseline IL-1 Level
Time Frame: baseline
|
baseline
|
6 month IL-1 Level
Time Frame: 6 months
|
6 months
|
12 month IL-1 Level
Time Frame: 12 months
|
12 months
|
18 month IL-1 Level
Time Frame: 18 months
|
18 months
|
24 month IL-1 Level
Time Frame: 24 months
|
24 months
|
Baseline Plasma Renin Activity
Time Frame: baseline
|
baseline
|
6 month Plasma Renin Activity
Time Frame: 6 month
|
6 month
|
12 month Plasma Renin Activity
Time Frame: 12 month
|
12 month
|
18 month Plasma Renin Activity
Time Frame: 18 month
|
18 month
|
24 month Plasma Renin Activity
Time Frame: 24 month
|
24 month
|
Baseline serum normetanephrine level
Time Frame: baseline
|
baseline
|
6 month serum normetanephrine level
Time Frame: 6 month
|
6 month
|
12 month serum normetanephrine level
Time Frame: 12 month
|
12 month
|
18 month serum normetanephrine level
Time Frame: 18 month
|
18 month
|
24 month serum normetanephrine level
Time Frame: 24 month
|
24 month
|
Baseline 11-deoxycortisol level
Time Frame: baseline
|
baseline
|
6 month 11-deoxycortisol level
Time Frame: 6 months
|
6 months
|
12 month 11-deoxycortisol level
Time Frame: 12 months
|
12 months
|
18 month 11-deoxycortisol level
Time Frame: 18 months
|
18 months
|
24 month 11-deoxycortisol level
Time Frame: 24 months
|
24 months
|
Baseline HDL level
Time Frame: baseline
|
baseline
|
6 month HDL level
Time Frame: 6 months
|
6 months
|
12 month HDL level
Time Frame: 12 months
|
12 months
|
18 month HDL level
Time Frame: 18 months
|
18 months
|
24 month HDL level
Time Frame: 24 months
|
24 months
|
Baseline IL-6 level
Time Frame: baseline
|
baseline
|
6 month IL-6 level
Time Frame: 6 months
|
6 months
|
12 month IL-6 level
Time Frame: 12 months
|
12 months
|
18 month IL-6 level
Time Frame: 18 months
|
18 months
|
24 month IL-6 level
Time Frame: 24 months
|
24 months
|
Baseline IL-10 level
Time Frame: baseline
|
baseline
|
6 month IL-10 level
Time Frame: 6 months
|
6 months
|
12 month IL-10 level
Time Frame: 12 months
|
12 months
|
18 month IL-10 level
Time Frame: 18 months
|
18 months
|
24 month IL-10 level
Time Frame: 24 months
|
24 months
|
Baseline TNFa level
Time Frame: baseline
|
baseline
|
6 month TNFa level
Time Frame: 6 months
|
6 months
|
12 month TNFa level
Time Frame: 12 months
|
12 months
|
18 month TNFa level
Time Frame: 18 months
|
18 months
|
24 month TNFa level
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Annualized Incidence of RAI
Time Frame: over two years
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over two years
|
30-day transplant-free survival
Time Frame: 30 days
|
30 days
|
90-day transplant-free survival
Time Frame: 90 days
|
90 days
|
6-month transplant-free survival
Time Frame: 6 months
|
6 months
|
1 year transplant-free survival
Time Frame: 1 year
|
1 year
|
2 year transplant-free survival
Time Frame: 2 years
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2 years
|
30 day new or worsened portal hypertensive decompensation
Time Frame: 30 days
|
30 days
|
90 day new or worsened portal hypertensive decompensation
Time Frame: 90 days
|
90 days
|
6 month new or worsened portal hypertensive decompensation
Time Frame: 6 months
|
6 months
|
1 year new or worsened portal hypertensive decompensation
Time Frame: 1 year
|
1 year
|
2 year new or worsened portal hypertensive decompensation
Time Frame: 2 years
|
2 years
|
30 day unplanned hospitalization
Time Frame: 30 days
|
30 days
|
90 day unplanned hospitalization
Time Frame: 90 days
|
90 days
|
6 month unplanned hospitalization
Time Frame: 6 month
|
6 month
|
1 year unplanned hospitalization
Time Frame: 1 year
|
1 year
|
2 year unplanned hospitalization
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2021
Primary Completion (Actual)
June 30, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 24, 2020
Study Record Updates
Last Update Posted (Estimated)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 10, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR200392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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