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临床试验/NCT02990923
NCT02990923Unknown4 期

The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial

Peking University First Hospital0 个研究点目标入组 102 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
102
主要终点
Catheter-related bloodstream infection

研究概览

简要总结

The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
  • •Have signed information consent form

排除标准

  • •Have got bacteremia before catheter implantation
  • •Catheter changing in situ

研究组 & 干预措施

Control

No Intervention

In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management

Only High-Flow Valve

Experimental

In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management

干预措施: High-Flow Needleless Valve (Device)

Both Divices

Experimental

In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis

干预措施: High-Flow Needleless Valve (Device)

Both Divices

Experimental

In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis

干预措施: DualCap Disinfection Devices (Device)

结局指标

主要结局

Catheter-related bloodstream infection

时间窗: through study completion, an average of 1 year

次要结局

  • Number of participants with catheter withdraw for any reason(through study completion, an average of 1 year)
  • Number of participants with catheter dysfunction(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rong Xu

vice professor

Peking University First Hospital

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