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CirrhosisNCT04642391

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

An observational study of Cirrhosis and Adrenal Insufficiency, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cirrhosis, Adrenal Insufficiency
What is being tested?
Cosyntropin
How many people
76 participants
Where
1 siteUnited States
Study dates
2 Aug 2021to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Decompensated cirrhosis (cirrhosis + at least 1 clinically-significant decompensation including ascites/hepatic hydrothorax, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: 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.

Being tested
Cosyntropin
Medical subject headings
Fibrosis, Adrenal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CosyntropinDrug

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

Study groups in NCT04642391
Study groupRoleWhat they receive
RAISubjects 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.
Receives: Drug: Cosyntropin
Non-RAISubjects 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.
Receives: Drug: Cosyntropin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RAI prevalence

    Measured: 1 year

  2. Baseline Cholesterol Esterification Percentage

    Measured: baseline

  3. 6 month Cholesterol Esterification Percentage

    Measured: 6 months

  4. 12 month Cholesterol Esterification Percentage

    Measured: 12 months

  5. 18 month Cholesterol Esterification Percentage

    Measured: 18 months

  6. 24 month Cholesterol Esterification Percentage

    Measured: 24 months

  7. Baseline 17-OH Progesterone Level

    Measured: baseline

  8. 6 month 17-OH Progesterone Level

    Measured: 6 month

  9. 12 month 17-OH Progesterone Level

    Measured: 12 months

  10. 18 month 17-OH Progesterone Level

    Measured: 18 months

  11. 24 month 17-OH Progesterone Level

    Measured: 24 months

  12. Baseline ACTH level

    Measured: baseline

  13. 6 month ACTH level

    Measured: 6 months

  14. 12 month ACTH level

    Measured: 12 months

  15. 18 month ACTH level

    Measured: 18 months

  16. 24 month ACTH level

    Measured: 24 months

  17. Baseline IL-1 Level

    Measured: baseline

  18. 6 month IL-1 Level

    Measured: 6 months

  19. 12 month IL-1 Level

    Measured: 12 months

  20. 18 month IL-1 Level

    Measured: 18 months

  21. 24 month IL-1 Level

    Measured: 24 months

  22. Baseline Plasma Renin Activity

    Measured: baseline

  23. 6 month Plasma Renin Activity

    Measured: 6 month

  24. 12 month Plasma Renin Activity

    Measured: 12 month

  25. 18 month Plasma Renin Activity

    Measured: 18 month

  26. 24 month Plasma Renin Activity

    Measured: 24 month

  27. Baseline serum normetanephrine level

    Measured: baseline

  28. 6 month serum normetanephrine level

    Measured: 6 month

  29. 12 month serum normetanephrine level

    Measured: 12 month

  30. 18 month serum normetanephrine level

    Measured: 18 month

  31. 24 month serum normetanephrine level

    Measured: 24 month

  32. Baseline 11-deoxycortisol level

    Measured: baseline

  33. 6 month 11-deoxycortisol level

    Measured: 6 months

  34. 12 month 11-deoxycortisol level

    Measured: 12 months

  35. 18 month 11-deoxycortisol level

    Measured: 18 months

  36. 24 month 11-deoxycortisol level

    Measured: 24 months

  37. Baseline HDL level

    Measured: baseline

  38. 6 month HDL level

    Measured: 6 months

  39. 12 month HDL level

    Measured: 12 months

  40. 18 month HDL level

    Measured: 18 months

  41. 24 month HDL level

    Measured: 24 months

  42. Baseline IL-6 level

    Measured: baseline

  43. 6 month IL-6 level

    Measured: 6 months

  44. 12 month IL-6 level

    Measured: 12 months

  45. 18 month IL-6 level

    Measured: 18 months

  46. 24 month IL-6 level

    Measured: 24 months

  47. Baseline IL-10 level

    Measured: baseline

  48. 6 month IL-10 level

    Measured: 6 months

  49. 12 month IL-10 level

    Measured: 12 months

  50. 18 month IL-10 level

    Measured: 18 months

  51. 24 month IL-10 level

    Measured: 24 months

  52. Baseline TNFa level

    Measured: baseline

  53. 6 month TNFa level

    Measured: 6 months

  54. 12 month TNFa level

    Measured: 12 months

  55. 18 month TNFa level

    Measured: 18 months

  56. 24 month TNFa level

    Measured: 24 months

Secondary outcomes (16)

  1. Annualized Incidence of RAI

    Measured: over two years

  2. 30-day transplant-free survival

    Measured: 30 days

  3. 90-day transplant-free survival

    Measured: 90 days

  4. 6-month transplant-free survival

    Measured: 6 months

  5. 1 year transplant-free survival

    Measured: 1 year

  6. 2 year transplant-free survival

    Measured: 2 years

  7. 30 day new or worsened portal hypertensive decompensation

    Measured: 30 days

  8. 90 day new or worsened portal hypertensive decompensation

    Measured: 90 days

  9. 6 month new or worsened portal hypertensive decompensation

    Measured: 6 months

  10. 1 year new or worsened portal hypertensive decompensation

    Measured: 1 year

  11. 2 year new or worsened portal hypertensive decompensation

    Measured: 2 years

  12. 30 day unplanned hospitalization

    Measured: 30 days

  13. 90 day unplanned hospitalization

    Measured: 90 days

  14. 6 month unplanned hospitalization

    Measured: 6 month

  15. 1 year unplanned hospitalization

    Measured: 1 year

  16. 2 year unplanned hospitalization

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start2 Aug 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642391
Sponsor's protocol ID
HSR200392
Status last verified
Dec 2024
First submitted
17 Nov 2020
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Adrenal Insufficiency, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RAI prevalence (time frame: 1 year). The study lists 56 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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