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Trial · Observational

CompletedPhase not statedRegistry data

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

NCTNCT04642391 (opens ClinicalTrials.gov in a new tab)Other idHSR200392
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
76 participants (actual)
Sponsor
University of Virginia · Other
Design
Not stated
Countries
1 country

United States

Start
2 Aug 2021
Primary completion
30 Jun 2023
Completion
30 Jun 2024
First posted
24 Nov 2020
Last update posted
10 Dec 2024
Conditions
Cirrhosis · Adrenal Insufficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. Ph –

    Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

    NCT04642391

    2 Aug 2021 to 30 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CosyntropinDrug

Arms2

  • Other

    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.

  • Other

    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.

Primary outcomes56

Outcomes the sponsor listed as primary.

  1. RAI prevalence

    Time frame · 1 year

  2. Baseline Cholesterol Esterification Percentage

    Time frame · baseline

  3. 6 month Cholesterol Esterification Percentage

    Time frame · 6 months

  4. 12 month Cholesterol Esterification Percentage

    Time frame · 12 months

  5. 18 month Cholesterol Esterification Percentage

    Time frame · 18 months

  6. 24 month Cholesterol Esterification Percentage

    Time frame · 24 months

  7. Baseline 17-OH Progesterone Level

    Time frame · baseline

  8. 6 month 17-OH Progesterone Level

    Time frame · 6 month

  9. 12 month 17-OH Progesterone Level

    Time frame · 12 months

  10. 18 month 17-OH Progesterone Level

    Time frame · 18 months

  11. 24 month 17-OH Progesterone Level

    Time frame · 24 months

  12. Baseline ACTH level

    Time frame · baseline

  13. 6 month ACTH level

    Time frame · 6 months

  14. 12 month ACTH level

    Time frame · 12 months

  15. 18 month ACTH level

    Time frame · 18 months

  16. 24 month ACTH level

    Time frame · 24 months

  17. Baseline IL-1 Level

    Time frame · baseline

  18. 6 month IL-1 Level

    Time frame · 6 months

  19. 12 month IL-1 Level

    Time frame · 12 months

  20. 18 month IL-1 Level

    Time frame · 18 months

  21. 24 month IL-1 Level

    Time frame · 24 months

  22. Baseline Plasma Renin Activity

    Time frame · baseline

  23. 6 month Plasma Renin Activity

    Time frame · 6 month

  24. 12 month Plasma Renin Activity

    Time frame · 12 month

  25. 18 month Plasma Renin Activity

    Time frame · 18 month

  26. 24 month Plasma Renin Activity

    Time frame · 24 month

  27. Baseline serum normetanephrine level

    Time frame · baseline

  28. 6 month serum normetanephrine level

    Time frame · 6 month

  29. 12 month serum normetanephrine level

    Time frame · 12 month

  30. 18 month serum normetanephrine level

    Time frame · 18 month

  31. 24 month serum normetanephrine level

    Time frame · 24 month

  32. Baseline 11-deoxycortisol level

    Time frame · baseline

  33. 6 month 11-deoxycortisol level

    Time frame · 6 months

  34. 12 month 11-deoxycortisol level

    Time frame · 12 months

  35. 18 month 11-deoxycortisol level

    Time frame · 18 months

  36. 24 month 11-deoxycortisol level

    Time frame · 24 months

  37. Baseline HDL level

    Time frame · baseline

  38. 6 month HDL level

    Time frame · 6 months

  39. 12 month HDL level

    Time frame · 12 months

  40. 18 month HDL level

    Time frame · 18 months

  41. 24 month HDL level

    Time frame · 24 months

  42. Baseline IL-6 level

    Time frame · baseline

  43. 6 month IL-6 level

    Time frame · 6 months

  44. 12 month IL-6 level

    Time frame · 12 months

  45. 18 month IL-6 level

    Time frame · 18 months

  46. 24 month IL-6 level

    Time frame · 24 months

  47. Baseline IL-10 level

    Time frame · baseline

  48. 6 month IL-10 level

    Time frame · 6 months

  49. 12 month IL-10 level

    Time frame · 12 months

  50. 18 month IL-10 level

    Time frame · 18 months

  51. 24 month IL-10 level

    Time frame · 24 months

  52. Baseline TNFa level

    Time frame · baseline

  53. 6 month TNFa level

    Time frame · 6 months

  54. 12 month TNFa level

    Time frame · 12 months

  55. 18 month TNFa level

    Time frame · 18 months

  56. 24 month TNFa level

    Time frame · 24 months

Secondary outcomes(16)

  1. Annualized Incidence of RAI

    Time frame · over two years

  2. 30-day transplant-free survival

    Time frame · 30 days

  3. 90-day transplant-free survival

    Time frame · 90 days

  4. 6-month transplant-free survival

    Time frame · 6 months

  5. 1 year transplant-free survival

    Time frame · 1 year

  6. 2 year transplant-free survival

    Time frame · 2 years

  7. 30 day new or worsened portal hypertensive decompensation

    Time frame · 30 days

  8. 90 day new or worsened portal hypertensive decompensation

    Time frame · 90 days

  9. 6 month new or worsened portal hypertensive decompensation

    Time frame · 6 months

  10. 1 year new or worsened portal hypertensive decompensation

    Time frame · 1 year

  11. 2 year new or worsened portal hypertensive decompensation

    Time frame · 2 years

  12. 30 day unplanned hospitalization

    Time frame · 30 days

  13. 90 day unplanned hospitalization

    Time frame · 90 days

  14. 6 month unplanned hospitalization

    Time frame · 6 month

  15. 1 year unplanned hospitalization

    Time frame · 1 year

  16. 2 year unplanned hospitalization

    Time frame · 2 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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