Clinical trial NCT05670964: Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis
Official title: EValuation of the Impact of the UPLUG DEvice Onto the iNfection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic hEmodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Disease, Chronic
Hemodialysis Catheter Infection
Keywords: Central venous catheter
UPLUG
Infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centered open labelled two-arm randomized (1:1) superiority trial. One arm will have standard dialysis, the other arm will have dialysis using the UPLUG device
Primary purpose: TREATMENT

Brief 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

Detailed description: 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 :

1. 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
2. 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.

Follow-up period (29 days):

A last visit (onsite or call) is planned during the definitive withdrawal of the CVC or no later than 29 days after the end of the treatment period (D113) to assess the safety and well-being of the patient

Eligibility criteria: 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

Primary outcomes:
measure: Number of bacterial infection within the 16 weeks of treatment period
timeFrame: 16 weeks
Secondary outcomes:
measure: 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
timeFrame: Day 29, Day 57, Day 85 and Day 113
measure: Number of positive blood culture during the 16 weeks of the treatment period evaluated at Day 29, Day 57, Day 85 and Day 113
timeFrame: Day 29, Day 57, Day 85 and Day 113
measure: Number of dysfunction estimated by blood flow rate (Qb) evaluated at Day 29, Day 57, Day 85 and Day 113
timeFrame: Day 29, Day 57, Day 85 and Day 113
measure: Number of adverse events during the 16 weeks of treatment period evaluated at D29, D57, D85 and D113
timeFrame: D29, D57, D85 and D113
measure: Number of infections other than bacterial during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113
timeFrame: Day 29, Day 57, Day 85, Day 113
measure: The patient satisfaction
timeFrame: Day 1, Day 29, Day 57, Day 85, Day 113, Day 141
measure: 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
timeFrame: Day 29, Day 57, Day 85, Day 113
measure: Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113
timeFrame: Day 29, Day 57, Day 85, Day 113
measure: Rate of unplanned hospitalisation at Day 113 and at the end of the study
timeFrame: Day 113, Day 141
measure: Time spent by session by the nurse to connect the patient at Day 1, Day 29, Day 57, Day 85 and Day 113
timeFrame: Day 1, Day 29, Day 57, Day 85, Day 113
measure: The nurse satisfaction for the patients in UPLUG arm
timeFrame: Day 1, Day 113
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Tenon, service de Néphrologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hafedh FESSI, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique JOLY, PUPH
role: STUDY_DIRECTOR
References: