Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- success in performing dialysis
研究概览
简要总结
The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.
Aim:
The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.
Material and methods:
This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.
Hypothesis tested:
The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.
详细描述
The incidence and prevalence of chronic insufficiency have been growing for several years. Increasingly older patients are treated with chronic hemodialysis. The vascular access of choice remains the arteriovenous fistula and the proportion of hemodialysis patients on the permanent central venous hemodialysis catheter varies from 20 to 35% in dialysis centres. The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.
Aim:
The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.
Material and methods:
This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •with end-stage chronic renal failure treated by hemodialysis (2 or 3 sessions per week)
- •Wearer of a right or left jugular permanent tunneled central venous hemodialysis catheter whose end has been in the superior vena cava or the right atrium for at least 1 month
- •Hemodialysis catheter lock used = heparin or 4% citrate
- •Expected life expectancy > 6 months
- •Dialysis session preceding inclusion with an average blood flow of at least 300ml/min
排除标准
- •Patient with a mechanical heart valve
- •Patient with an arteriovenous fistula (AVF) that can be used within one month
- •Kidney transplant by living donor planned in the following month
- •Pregnant or breastfeeding woman
- •History of infection on the hemodialysis catheter in place dating from less than 6 months
- •Psychiatric or demented patient unable to obtain informed consent
- •Patient already included in another protocol
研究组 & 干预措施
use of the device during hemodialysis sessions
use of the device during one month during hemodialysis sessions
干预措施: UPLUG Hemodialysis Connection Device (Device)
结局指标
主要结局
success in performing dialysis
时间窗: one month
Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%.
次要结局
- patient satisfaction(one month)
- experimental device integrity(one month)
- clinical performance of device(one month)
- nurses' satisfaction(one month)
- Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG(one month)