Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- renin-angiotensin-aldosterone activation
研究概览
简要总结
The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction
详细描述
Large-volume paracentesis associated with plasma volume expansion is the first-line treatment of tense ascites in cirrhotic patients. When paracentesis is performed without volume expansion, an high proportion of patients develop a complication named post-paracentesis circulatory dysfunction, which is characterized by a marked activation of the renin-angiotensin-aldosterone system. PPCD has been associated with renal impairment, rapid recurrence of ascites and shorter survival. Infusion of albumin is very effective in the prevention of PPCD, but has sever inherent drawbacks: the theoretical possibility of transmission of infectious diseases and the high costs. Other synthetic plasma volume expanders have been proposed in the last decades, but they are less effective than albumin when large (> 5 L) volume paracentesis are performed. Albumin is conventionally given in a dosage of 8 gr per liter of ascites removed; however no information has yet been reported on the use of lower dosages of albumin in this context. This would be interesting, because of the obvious advantages in terms of costs reduction.
The aim of the present study is to compare the efficacy of the infusion of albumin 4 gr vs 8 gr per liter of ascites removed in the prevention of PPCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 and ascites submitted to paracentesis > 5 liters
- •Age: 18-75 years
- •Informed written consent
排除标准
- •Multinodular HCC (> 3 nodules)
- •Portal vein thrombosis
- •Ongoing bacterial infection
- •Ongoing or recent (less than one week) bleeding
- •Cardio-pulmonary failure
- •Hepatorenal syndrome type 1
- •Severe coagulopathy: platelets < 30.000/mm3 and/or PT < 30%
- •Ongoing treatment with vasoactive drugs
结局指标
主要结局
renin-angiotensin-aldosterone activation
时间窗: 4-6 days
次要结局
- renal function(4-6 days)
