Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Proportion of patients without hepatic encephalopathy
研究概览
简要总结
The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.
详细描述
Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. The most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. Current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. Brain edema and abnormalities of cerebral blood flow appear to be important. Part of the impairment of astrocyte function could be related to an increase of oxidative stress injury.
In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. Administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. Albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect.
The administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cirrhosis of the liver
- •Hepatic encephalopathy stage>1
- •Completion of a standardized protocol to investigate precipitating factors
- •Informed consent by next of keen
排除标准
- •Pregnancy
- •Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy)
- •Need of advanced life support (mechanical ventilation, ionotropic support, dialysis)
- •Need of albumin administration (e.g. bacterial spontaneous peritonitis)
- •Contraindication for albumin administration (e.g. cardiac failure)
研究组 & 干预措施
Albumin
干预措施: Albumin (Drug)
Saline
干预措施: Sodium chloride 0.9% (Drug)
结局指标
主要结局
Proportion of patients without hepatic encephalopathy
时间窗: Day 3
次要结局
- Severity of encephalopathy assessed by CHESS and West-Haven(Admission to the hospital (up to day 14))
