跳至主要内容
临床试验/NCT03633435
NCT03633435Unknown不适用

Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
failure of assisted- HDD

研究概览

简要总结

Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

详细描述

  • Monocentric prospective interventional study.
  • Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One
  • pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging.
  • primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

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

入选标准

  • The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law.
  • Exclusion criteria:
  • medical contra-indication for HHD

排除标准

  • 未提供

结局指标

主要结局

failure of assisted- HDD

时间窗: 12months

definitive cessation of HHD with transfer to an other dialysis modality.

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 (2)

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