Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous… (NCT05670964) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis
Stopped: liquidation of the compagny
France7 participantsStarted 2023-10-16
Plain-language summary
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 :
1. reduce the haemodialysis catheter openings, hence potentially reducing the infectious risk,
2. improve the lock solution infusion using a positive pressure, limiting the thrombosis risk and associated haemodialysis catheter dysfunction
3. 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
4. ultimately enhance patient's autonomy with ergonomics \& safe procedures
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* End-stage renal disease
* Chronic haemodialysis
* indwelling de novo or replacement central veinous catheter
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of bacterial infection within the 16 weeks of treatment period