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| Name | Class |
|---|---|
| American Association for the Study of Liver Diseases | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosyntropin | Drug | Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| RAI prevalence | 1 year | |
| Baseline Cholesterol Esterification Percentage | baseline | |
| 6 month Cholesterol Esterification Percentage | 6 months | |
| 12 month Cholesterol Esterification Percentage | 12 months | |
| 18 month Cholesterol Esterification Percentage | 18 months | |
| 24 month Cholesterol Esterification Percentage | 24 months | |
| Baseline 17-OH Progesterone Level | baseline | |
| 6 month 17-OH Progesterone Level | 6 month | |
| 12 month 17-OH Progesterone Level | 12 months | |
| 18 month 17-OH Progesterone Level | 18 months | |
| 24 month 17-OH Progesterone Level | 24 months | |
| Baseline ACTH level |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Incidence of RAI | over two years | |
| 30-day transplant-free survival | 30 days | |
| 90-day transplant-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Decompensated cirrhosis (cirrhosis + at least 1 clinically-significant decompensation including ascites/hepatic hydrothorax, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003366 | Cosyntropin |
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
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Human serum and plasma
| baseline |
| 6 month ACTH level | 6 months |
| 12 month ACTH level | 12 months |
| 18 month ACTH level | 18 months |
| 24 month ACTH level | 24 months |
| Baseline IL-1 Level | baseline |
| 6 month IL-1 Level | 6 months |
| 12 month IL-1 Level | 12 months |
| 18 month IL-1 Level | 18 months |
| 24 month IL-1 Level | 24 months |
| Baseline Plasma Renin Activity | baseline |
| 6 month Plasma Renin Activity | 6 month |
| 12 month Plasma Renin Activity | 12 month |
| 18 month Plasma Renin Activity | 18 month |
| 24 month Plasma Renin Activity | 24 month |
| Baseline serum normetanephrine level | baseline |
| 6 month serum normetanephrine level | 6 month |
| 12 month serum normetanephrine level | 12 month |
| 18 month serum normetanephrine level | 18 month |
| 24 month serum normetanephrine level | 24 month |
| Baseline 11-deoxycortisol level | baseline |
| 6 month 11-deoxycortisol level | 6 months |
| 12 month 11-deoxycortisol level | 12 months |
| 18 month 11-deoxycortisol level | 18 months |
| 24 month 11-deoxycortisol level | 24 months |
| Baseline HDL level | baseline |
| 6 month HDL level | 6 months |
| 12 month HDL level | 12 months |
| 18 month HDL level | 18 months |
| 24 month HDL level | 24 months |
| Baseline IL-6 level | baseline |
| 6 month IL-6 level | 6 months |
| 12 month IL-6 level | 12 months |
| 18 month IL-6 level | 18 months |
| 24 month IL-6 level | 24 months |
| Baseline IL-10 level | baseline |
| 6 month IL-10 level | 6 months |
| 12 month IL-10 level | 12 months |
| 18 month IL-10 level | 18 months |
| 24 month IL-10 level | 24 months |
| Baseline TNFa level | baseline |
| 6 month TNFa level | 6 months |
| 12 month TNFa level | 12 months |
| 18 month TNFa level | 18 months |
| 24 month TNFa level | 24 months |
| 90 days |
| 6-month transplant-free survival | 6 months |
| 1 year transplant-free survival | 1 year |
| 2 year transplant-free survival | 2 years |
| 30 day new or worsened portal hypertensive decompensation | 30 days |
| 90 day new or worsened portal hypertensive decompensation | 90 days |
| 6 month new or worsened portal hypertensive decompensation | 6 months |
| 1 year new or worsened portal hypertensive decompensation | 1 year |
| 2 year new or worsened portal hypertensive decompensation | 2 years |
| 30 day unplanned hospitalization | 30 days |
| 90 day unplanned hospitalization | 90 days |
| 6 month unplanned hospitalization | 6 month |
| 1 year unplanned hospitalization | 1 year |
| 2 year unplanned hospitalization | 2 year |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |