Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis

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 dysfunctionlimit 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 professionalultimately enhance patient's autonomy with ergonomics & safe procedures

Inclusion Criteria:End-stage renal diseaseChronic haemodialysisindwelling de novo or replacement central veinous catheterExclusion Criteria:Life expectancy < 1 yearRenal transplantation already scheduled at inclusion (living donor)Current infection of CVC percutaneous or subcutaneous sitePregnant or breastfeeding female, or women without a medically significant contraceptive regimenPatient with mechanical heart valvePatient with an AVF likely to be functional within 1 monthStrictly more than 3 dialysis sessions a weekPatient undergoing haemodialysis session > 4h30Participation to another clinical study in the last 30 days periodPatient unable to give a freely-given, written, informed consentVulnerable participants