Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

Hemodialysis Clinical Trial

— UPLUG-SAFE  

Official title:

Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419258
• Other study ID #: 21-0265
• Status: Completed
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• UPLUG Hemodialysis Connection Device
use of the device UPLUG during 1 month

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	experimental device integrity	device deficiencies reported from consent to end of study	one month
Secondary	nurses' satisfaction	satisfaction evaluated by questionnaire before and after the inclusions	one month
Secondary	patient satisfaction	satisfaction evaluated by questionnaire before and after the use of experimental device	one month
Secondary	clinical performance of device	performance measured by rate of successful sessions	one month