NCT01438970Unknown2 期
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function in Patients With Cirrhosis and Recurrent or Refractory Ascites
Sequana Medical N.V.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.
研究概览
简要总结
This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:
- To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
- To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
- To determine the incidence of complications associated with treatment in the course of follow-up.
- To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
- •Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
- •Written informed consent
- •Ability to comply with study procedures and ability to operate the device
- •Women of childbearing age should use adequate contraceptives
排除标准
- •Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
- •Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
- •Serum bilirubin greater than 5 mg/dl.
- •Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
- •Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
- •Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
- •Clinical evidence of loculated ascites.
- •Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
- •Previous liver transplant.
- •Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
- •Patients being in another clinical study that did not reach primary endpoint yet
结局指标
主要结局
The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.
时间窗: One month
次要结局
未报告次要终点
研究者
研究点 (2)
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