Skip to main content
OpenTrials
Completed

NCT Number: NCT04642391

Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Adrenal Gland Diseases Adrenal Insufficiency Endocrine System Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosyntropin

Drug

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

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • American Association for the Study of Liver Diseases

Registry information

Official study title

Defining the Mechanisms Underlying Adrenal Dysfunction in Cirrhosis and Its Prognostic Significance

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 24, 2020
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.