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Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis

NCT05670964 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-05-16

No results posted yet for this study

Summary

Infections are common complications among patients on chronic haemodialysis. Haemodialysis patients with a catheter have a 2- to 3-fold increased risk of hospitalization for infection and death compared with patients with an arteriovenous fistula or graft \[0\].

As it is a major concern for the medical community, this clinical investigation aims at assessing, in real world conditions, the impact of the UPLUG device onto the infection rate of indwelling central venous haemodialysis catheters.

UPLUG-EVIDENCE is an international, multicenter, randomised, open label trial that will evaluate the efficacy of the UPLUG device on the reduction of bacterial infections in patients undergoing chronic haemodialysis with central venous catheter (CVC).

The UPLUG device has been designed to :

1. reduce the haemodialysis catheter openings, hence potentially reducing the infectious risk,
2. improve the lock solution infusion using a positive pressure, limiting the thrombosis risk and associated haemodialysis catheter dysfunction
3. limit the time needed to connect and disconnect the patient, by facilitating how the different steps are operated, and even allowing a connection/disconnection with a single healthcare professional
4. ultimately enhance patient's autonomy with ergonomics \& safe procedures

Conditions

  • Renal Disease, Chronic
  • Hemodialysis Catheter Infection

Interventions

DEVICE

Connecting valve system

UPLUG Port (changed every 29 days) and UPLUG Disposable (changed at every dialysis session) ensure the connection between a regular haemodialysis catheter and an extracorporeal circuit, and proceed to different steps of haemodialysis session without handling the Luer-Lock connectors of the haemodialysis catheter

DEVICE

Central haemodialysis Venous Catheter

Central haemodialysis venous catheter (CE marked) will be used within the scope of their intended purpose during the dialysis session

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Hafedh FESSI, PH · Assistance Publique - Hôpitaux de Paris

  • Dominique JOLY, PUPH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-03-25
Completion
2024-03-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670964 on ClinicalTrials.gov