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

NCT ID: NCT05670964

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-03-25

Brief 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

Detailed Description

A total of 464 end stage renal disease patients undergoing chronic haemodialysis and receiving a new (de novo or replacement) indwelling CVC will be randomly assigned in a 1:1 ratio to perform either standard-of-care dialysis (232) or standard-of-care dialysis associated with the UPLUG device (232).

The UPLUG device consists of 2 parts :

1. the UPLUG Port, a sterile, single use device connected to the distal Luer-Lock connectors of a regular central venous catheter. It may be connected up to 29 days and

2. the UPLUG Disposable, a sterile, single use device indicated for use with the UPLUG Port to perform a chronic haemodialysis therapy. it will be changed at every dialysis session.

Treatment period (16 weeks):

W1:D1 : first connection of the UPLUG Port The patient will be seen by a nurse or an investigator at D29, D57 and D85 for UPLUG port periodical replacement, and at D113 for the definitive withdrawal of the UPLUG port.

Follow-up period (29 days):

A last visit (onsite or call) is planned during the definitive withdrawal of the CVC or no later than 29 days after the end of the treatment period (D113) to assess the safety and well-being of the patient

Conditions

Renal Disease, Chronic; Hemodialysis Catheter Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UPLUG Arm

Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions.

Group Type: EXPERIMENTAL

Connecting valve system

Intervention Type: DEVICE

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

Central haemodialysis Venous Catheter

Intervention Type: DEVICE

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

Standard Of Care Arm

Patients will have regular central veinous catheter (standard of care) for their dialysis.

Group Type: OTHER

Central haemodialysis Venous Catheter

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

UPLUG Port; UPLUG Disposable

Eligibility Criteria

Inclusion Criteria

• End-stage renal disease
• Chronic haemodialysis
• indwelling de novo or replacement central veinous catheter

Exclusion Criteria

• Life expectancy < 1 year
• Renal transplantation already scheduled at inclusion (living donor)
• Current infection of CVC percutaneous or subcutaneous site
• Pregnant or breastfeeding female, or women without a medically significant contraceptive regimen
• Patient with mechanical heart valve
• Patient with an AVF likely to be functional within 1 month
• Strictly more than 3 dialysis sessions a week
• Patient undergoing haemodialysis session > 4h30
• Participation to another clinical study in the last 30 days period
• Patient unable to give a freely-given, written, informed consent
• Vulnerable participants

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hafedh FESSI, PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Dominique JOLY, PUPH

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Tenon, service de Néphrologie

Paris, , France

Countries

France

Other Identifiers

APHP211510

Identifier Type: -

Identifier Source: org_study_id