EValuation of the Impact of the UPLUG DEvice Onto the iNfection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic hEmodialysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of bacterial infection within the 16 weeks of treatment period
研究概览
简要总结
Infections are common complications among patients on chronic haemodialysis. Haemodialysis patients with a catheter have a 2- to 3-fold increased risk of hospitalization for infection and death compared with patients with an arteriovenous fistula or graft [0].
As it is a major concern for the medical community, this clinical investigation aims at assessing, in real world conditions, the impact of the UPLUG device onto the infection rate of indwelling central venous haemodialysis catheters.
UPLUG-EVIDENCE is an international, multicenter, randomised, open label trial that will evaluate the efficacy of the UPLUG device on the reduction of bacterial infections in patients undergoing chronic haemodialysis with central venous catheter (CVC).
The UPLUG device has been designed to :
- reduce the haemodialysis catheter openings, hence potentially reducing the infectious risk,
- improve the lock solution infusion using a positive pressure, limiting the thrombosis risk and associated haemodialysis catheter dysfunction
- limit the time needed to connect and disconnect the patient, by facilitating how the different steps are operated, and even allowing a connection/disconnection with a single healthcare professional
- ultimately enhance patient's autonomy with ergonomics & safe procedures
详细描述
A total of 464 end stage renal disease patients undergoing chronic haemodialysis and receiving a new (de novo or replacement) indwelling CVC will be randomly assigned in a 1:1 ratio to perform either standard-of-care dialysis (232) or standard-of-care dialysis associated with the UPLUG device (232).
The UPLUG device consists of 2 parts :
- the UPLUG Port, a sterile, single use device connected to the distal Luer-Lock connectors of a regular central venous catheter. It may be connected up to 29 days and
- the UPLUG Disposable, a sterile, single use device indicated for use with the UPLUG Port to perform a chronic haemodialysis therapy. it will be changed at every dialysis session.
Treatment period (16 weeks):
W1:D1 : first connection of the UPLUG Port The patient will be seen by a nurse or an investigator at D29, D57 and D85 for UPLUG port periodical replacement, and at D113 for the definitive withdrawal of the UPLUG port.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •End-stage renal disease
- •Chronic haemodialysis
- •indwelling de novo or replacement central veinous catheter
排除标准
- •Life expectancy < 1 year
- •Renal transplantation already scheduled at inclusion (living donor)
- •Current infection of CVC percutaneous or subcutaneous site
- •Pregnant or breastfeeding female, or women without a medically significant contraceptive regimen
- •Patient with mechanical heart valve
- •Patient with an AVF likely to be functional within 1 month
- •Strictly more than 3 dialysis sessions a week
- •Patient undergoing haemodialysis session > 4h30
- •Participation to another clinical study in the last 30 days period
- •Patient unable to give a freely-given, written, informed consent
- •Vulnerable participants
研究组 & 干预措施
UPLUG Arm
Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions.
干预措施: Connecting valve system (Device)
UPLUG Arm
Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions.
干预措施: Central haemodialysis Venous Catheter (Device)
Standard Of Care Arm
Patients will have regular central veinous catheter (standard of care) for their dialysis.
干预措施: Central haemodialysis Venous Catheter (Device)
结局指标
主要结局
Number of bacterial infection within the 16 weeks of treatment period
时间窗: 16 weeks
A clinical suspicion of bacterial infection is defined by : 1/ fever (T\>37.5°C) or Or 2/ rigor Or 3/ new pre-HD hypotension (systolic arterial pressure \<90mmHg) Or 4/ confusion and/or disorientation at the investigator's discretion and will lead to a confirmation of bacteraemia\*\*: Blood culture (BC) growing the same organism from : 1/ HD catheter and 2a/ Peripheral vein And/or 2b/ Dialysis bloodline
次要结局
- Time spent by session by the nurse to connect the patient at Day 1, Day 29, Day 57, Day 85 and Day 113(Day 1, Day 29, Day 57, Day 85, Day 113)
- Number of dysfunction estimated by blood flow rate (Qb) evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85 and Day 113)
- Number of positive blood culture during the 16 weeks of the treatment period evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85 and Day 113)
- Number of patients with at least one bacterial infection during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85, Day 113)
- Rate of unplanned hospitalisation at Day 113 and at the end of the study(Day 113, Day 141)
- Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85, Day 113)
- Number of clinical suspicion of bacterial infection during the 16 weeks of the treatment period, evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85 and Day 113)
- Number of adverse events during the 16 weeks of treatment period evaluated at D29, D57, D85 and D113(D29, D57, D85 and D113)
- Number of infections other than bacterial during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113(Day 29, Day 57, Day 85, Day 113)
- The nurse satisfaction for the patients in UPLUG arm(Day 1, Day 113)
- The patient satisfaction(Day 1, Day 29, Day 57, Day 85, Day 113, Day 141)