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

EValuation of the Impact of the UPLUG DEvice Onto the iNfection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic hEmodialysis

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

Study Overview

• Status: Terminated
• Conditions: Hemodialysis Catheter Infection; Renal Disease, Chronic
• Intervention / Treatment: Device: Connecting valve system; Device: Central haemodialysis Venous Catheter

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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Hôpital Tenon, service de Néphrologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UPLUG Arm; Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions.	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; Other Names: UPLUG Port; UPLUG Disposable; 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
Other: Standard Of Care Arm; Patients will have regular central veinous catheter (standard of care) for their dialysis.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bacterial infection within the 16 weeks of treatment period	A clinical suspicion of bacterial infection is defined by : 1/ fever (T>37.5°C) or Or 2/ rigor Or 3/ new pre-HD hypotension (systolic arterial pressure <90mmHg) Or 4/ confusion and/or disorientation at the investigator's discretion and will lead to a confirmation of bacteraemia**: Blood culture (BC) growing the same organism from : 1/ HD catheter and 2a/ Peripheral vein And/or 2b/ Dialysis bloodline	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clinical suspicion of bacterial infection during the 16 weeks of the treatment period, evaluated at Day 29, Day 57, Day 85 and Day 113	A clinical suspicion of bacterial infection is defined by one of the following : 1/ fever (T>37.5°C) Or 2/ rigor Or 3/ new pre-HD hypotension (systolic arterial pressure <90mmHg) Or 4/ confusion and/or disorientation at the investigator's discretion	Day 29, Day 57, Day 85 and Day 113
Number of positive blood culture during the 16 weeks of the treatment period evaluated at Day 29, Day 57, Day 85 and Day 113	Positive blood culture from one of the following : 1/ HD catheter Or 2/ Peripheral vein Or 3/ Dialysis bloodline	Day 29, Day 57, Day 85 and Day 113
Number of dysfunction estimated by blood flow rate (Qb) evaluated at Day 29, Day 57, Day 85 and Day 113	Dysfunction is defined as: Qb < 200 ml/min during 30 minutes in the course of one haemodialysis session; Or Mean Qb < 250 ml/min during two consecutive haemodialysis sessions"	Day 29, Day 57, Day 85 and Day 113
Number of adverse events during the 16 weeks of treatment period evaluated at D29, D57, D85 and D113	Adverse events defined as defectiveness of the device, defectiveness of the placement, thrombosis events and infections	D29, D57, D85 and D113
Number of infections other than bacterial during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113	Infections other than bacterial : viral, fungal, parasitic	Day 29, Day 57, Day 85, Day 113
The patient satisfaction	Patient satisfaction is assessed through : a specific UBIPLUG questionnaire and a questionnaire SF-36 (Short-Form 36 Health Survey)	Day 1, Day 29, Day 57, Day 85, Day 113, Day 141
Number of patients with at least one bacterial infection during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113	A clinical suspicion of bacterial infection is defined by : 1/ fever (T>37.5°C) or Or 2/ rigor Or 3/ new pre-HD hypotension (systolic arterial pressure <90mmHg) Or 4/ confusion and/or disorientation at the investigator's discretion and will lead to a confirmation of bacteraemia: Blood culture (BC) growing the same organism from : 1/ HD catheter and 2a/ Peripheral vein And/or 2b/ Dialysis bloodline	Day 29, Day 57, Day 85, Day 113
Rate of unplanned hospitalisation at Day 113 and at the end of the study	Unplanned hospitalisation including less than 12 hours	Day 113, Day 141
Time spent by session by the nurse to connect the patient at Day 1, Day 29, Day 57, Day 85 and Day 113	Measured time from the start of the catheter management to the start of the dialysis session	Day 1, Day 29, Day 57, Day 85, Day 113
The nurse satisfaction for the patients in UPLUG arm	Assessed through a specific UBIPLUG questionnaire	Day 1, Day 113
Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113	infections other than bacterial : viral, fungal, parasitic	Day 29, Day 57, Day 85, Day 113

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hafedh FESSI, PH, Assistance Publique - Hôpitaux de Paris; Study Director: Dominique JOLY, PUPH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Central venous catheter; Infection; UPLUG
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Infections; Communicable Diseases
• Other Study ID Numbers: APHP211510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No