NCT02401490Unknown4 期
Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 128
- 试验地点
- 7
- 主要终点
- Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
研究概览
简要总结
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
详细描述
To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 30, 90 and 180 days.
- to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period.
- To analyze whether albumin administration reduces hospitalization requirement.
- To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years.
- •Liver cirrhosis defined by previous clinical data or liver biopsy.
- •Presence of an episode of acute hepatic encephalopathy of grade>
- •Sign the informed consent
排除标准
- •Pregnant or breast-feeding.
- •Terminal illness.
- •Presence of Acute-on-chronic liver failure.
- •Needing for intensive support measures.
- •Active gastrointestinal bleeding.
- •neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy.
- •Clinical situations in which it is contraindicated to administer intravenous albumin.
- •MELD score less than 15 or greater than 25 at the time of inclusion
- •Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.
研究组 & 干预措施
Human albumin
Active Comparator
human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.
干预措施: Human albumin (Drug)
placebo
Placebo Comparator
saline serum 0.9%
干预措施: Placebo (Drug)
结局指标
主要结局
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
时间窗: 90 days
次要结局
- Survival at 180 days.(180 days)
研究者
研究点 (7)
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