Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

Not Applicable

Completed

• Conditions: Hemodialysis; Renal Insufficiency, Chronic

• Registration Number: NCT05419258
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study First Submitted: 2022-04-29
• Study Start: 2022-05-06
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-15
• Status Verified: 2023-07
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
success in performing dialysis	one month	Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG	one month	adverse events reported from consent to end of study
patient satisfaction	one month	satisfaction evaluated by questionnaire before and after the use of experimental device
experimental device integrity	one month	device deficiencies reported from consent to end of study
clinical performance of device	one month	performance measured by rate of successful sessions
nurses' satisfaction	one month	satisfaction evaluated by questionnaire before and after the inclusions

Trial Locations

Locations (1)

CHU Caen Normandie; 🇫🇷 Caen, France