Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
NCT ID: NCT05419258
Last Updated: 2024-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2022-05-06
2023-10-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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use of the device during hemodialysis sessions
use of the device during one month during hemodialysis sessions
UPLUG Hemodialysis Connection Device
use of the device UPLUG during 1 month
Interventions
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UPLUG Hemodialysis Connection Device
use of the device UPLUG during 1 month
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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CHU Caen Normandie
Caen, , France
Countries
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Other Identifiers
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21-0265
Identifier Type: -
Identifier Source: org_study_id
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