Defining the Mechanisms Underlying Adrenal Dysfunction in Cirrhosis and Its Prognostic Significance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 18 month ACTH level
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cosyntropin (Drug)
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.
干预措施: Cosyntropin (Drug)
结局指标
主要结局
18 month ACTH level
时间窗: 18 months
Baseline IL-6 level
时间窗: baseline
6 month IL-6 level
时间窗: 6 months
12 month IL-6 level
时间窗: 12 months
24 month IL-10 level
时间窗: 24 months
Baseline TNFa level
时间窗: baseline
6 month TNFa level
时间窗: 6 months
6 month ACTH level
时间窗: 6 months
18 month Plasma Renin Activity
时间窗: 18 month
RAI prevalence
时间窗: 1 year
12 month Cholesterol Esterification Percentage
时间窗: 12 months
Baseline Cholesterol Esterification Percentage
时间窗: baseline
6 month Cholesterol Esterification Percentage
时间窗: 6 months
18 month Cholesterol Esterification Percentage
时间窗: 18 months
24 month Cholesterol Esterification Percentage
时间窗: 24 months
Baseline 17-OH Progesterone Level
时间窗: baseline
6 month 17-OH Progesterone Level
时间窗: 6 month
12 month 17-OH Progesterone Level
时间窗: 12 months
12 month ACTH level
时间窗: 12 months
24 month ACTH level
时间窗: 24 months
Baseline IL-1 Level
时间窗: baseline
6 month IL-1 Level
时间窗: 6 months
12 month Plasma Renin Activity
时间窗: 12 month
18 month 17-OH Progesterone Level
时间窗: 18 months
24 month 17-OH Progesterone Level
时间窗: 24 months
Baseline ACTH level
时间窗: baseline
12 month IL-1 Level
时间窗: 12 months
18 month IL-1 Level
时间窗: 18 months
24 month IL-1 Level
时间窗: 24 months
Baseline Plasma Renin Activity
时间窗: baseline
6 month Plasma Renin Activity
时间窗: 6 month
24 month Plasma Renin Activity
时间窗: 24 month
Baseline serum normetanephrine level
时间窗: baseline
6 month serum normetanephrine level
时间窗: 6 month
12 month serum normetanephrine level
时间窗: 12 month
18 month serum normetanephrine level
时间窗: 18 month
24 month serum normetanephrine level
时间窗: 24 month
Baseline 11-deoxycortisol level
时间窗: baseline
6 month 11-deoxycortisol level
时间窗: 6 months
12 month 11-deoxycortisol level
时间窗: 12 months
24 month 11-deoxycortisol level
时间窗: 24 months
24 month IL-6 level
时间窗: 24 months
Baseline IL-10 level
时间窗: baseline
18 month 11-deoxycortisol level
时间窗: 18 months
Baseline HDL level
时间窗: baseline
6 month HDL level
时间窗: 6 months
12 month HDL level
时间窗: 12 months
18 month HDL level
时间窗: 18 months
24 month HDL level
时间窗: 24 months
18 month IL-6 level
时间窗: 18 months
6 month IL-10 level
时间窗: 6 months
12 month IL-10 level
时间窗: 12 months
18 month IL-10 level
时间窗: 18 months
12 month TNFa level
时间窗: 12 months
18 month TNFa level
时间窗: 18 months
24 month TNFa level
时间窗: 24 months
次要结局
- 90 day new or worsened portal hypertensive decompensation(90 days)
- 6 month new or worsened portal hypertensive decompensation(6 months)
- Annualized Incidence of RAI(over two years)
- 30-day transplant-free survival(30 days)
- 90-day transplant-free survival(90 days)
- 1 year transplant-free survival(1 year)
- 2 year transplant-free survival(2 years)
- 30 day new or worsened portal hypertensive decompensation(30 days)
- 6-month transplant-free survival(6 months)
- 1 year new or worsened portal hypertensive decompensation(1 year)
- 2 year new or worsened portal hypertensive decompensation(2 years)
- 1 year unplanned hospitalization(1 year)
- 30 day unplanned hospitalization(30 days)
- 90 day unplanned hospitalization(90 days)
- 6 month unplanned hospitalization(6 month)
- 2 year unplanned hospitalization(2 year)
研究者
Brian Wentworth, MD
Assistant Professor Medicine
University of Virginia