跳至主要内容
临床试验/NCT05419271
NCT05419271Unknown不适用

Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
16
试验地点
1
主要终点
Middle molecular weight toxins clearance

研究概览

简要总结

Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

详细描述

Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state.

Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called "push pulls" and uses internal convection.

This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.

The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •home hemodialysis since at least 2 weeks
  • •hemodialysis since at least 3 months

排除标准

  • 未提供

研究组 & 干预措施

free internal convection

No Intervention

session of dialysis with free internal convection

experimental convection

Experimental

session of dialysis with 9L internal convection

干预措施: home hemodialysis session with 9L internal convection (Procedure)

结局指标

主要结局

Middle molecular weight toxins clearance

时间窗: during hemodialysis procedure

Beta2-microglobulin levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Controlled Internal Convection in Low Flow... | 临床试验