Clinical trial NCT05419258: Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Official title: Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Renal Insufficiency, Chronic
Keywords: medical device
connection medical device
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: feasibility study on medical device
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Hypothesis tested:

The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.

The secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: success in performing dialysis
timeFrame: one month
Secondary outcomes:
measure: Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG
timeFrame: one month
measure: experimental device integrity
timeFrame: one month
measure: nurses' satisfaction
timeFrame: one month
measure: patient satisfaction
timeFrame: one month
measure: clinical performance of device
timeFrame: one month
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: