Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device (UPLUG-SAFE)

Caen University Hospital

Status

Completed

Conditions

Hemodialysis

Renal Insufficiency, Chronic

Treatments

Device: UPLUG Hemodialysis Connection Device

Study type

Interventional

Funder types

Other

Identifiers

NCT05419258

21-0265

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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