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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Hemodialysis
• Intervention / Treatment: Device: UPLUG Hemodialysis Connection Device

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU Caen Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: use of the device during hemodialysis sessions; use of the device during one month during hemodialysis sessions	Device: UPLUG Hemodialysis Connection Device; use of the device UPLUG during 1 month

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: medical device; connection medical device
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 21-0265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No