NCT00657306Unknown2 期
Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- renal function
研究概览
简要总结
Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.
Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with ascites, with or without hepatorenal syndrome
排除标准
- •Age < 18 and > 75 years
- •Shock or bacterial infection present at the inclusion or during the previous week
- •Bleeding present at the inclusion or during the previous week
- •Multifocal HCC
- •Organic renal failure
- •Hearth or pulmonary failure
研究组 & 干预措施
1
Experimental
Hydrocortisone, 50 mg/6 h per day
干预措施: hydrocortisone (Drug)
2
Placebo Comparator
dextrose solution 5%
干预措施: dextrose solution 5% (Drug)
结局指标
主要结局
renal function
时间窗: 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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