跳至主要内容
临床试验/NCT00428506
NCT00428506Unknown2 期

Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2007年2月1日最近更新:
适应症
相关药物

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

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)

研究者

发起方
University of Turin, Italy
申办方类型
Other

研究点 (2)

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