Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

December 4, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Cosyntropin
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.
Drug: Cosyntropin
Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Annualized Incidence of RAI
Time Frame: over two years
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Association for the Study of Liver Diseases

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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