Status:
COMPLETED
Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device
Lead Sponsor:
University Hospital, Caen
Conditions:
Hemodialysis
Renal Insufficiency, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05419258
Start Date
May 6 2022
End Date
October 30 2023
Last Update
February 13 2024
Active Locations (1)
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1
CHU Caen Normandie
Caen, France, 14000