Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

Conditions
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Hemodialysis, Renal Insufficiency, Chronic

Intervention / Treatment
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* Device: UPLUG Hemodialysis Connection Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: feasibility study on medical device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: use of the device during hemodialysis sessions<br>use of the device during one month during hemodialysis sessions | Device: UPLUG Hemodialysis Connection Device<br>* use of the device UPLUG during 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success in performing dialysis | 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%. | one month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical device, connection medical device