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

NCT05670964 | Terminated DMC

• 1 other identifier: APHP211510
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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. 1.reduce the haemodialysis catheter openings, hence potentially reducing the infectious risk,
2. 2.improve the lock solution infusion using a positive pressure, limiting the thrombosis risk and associated haemodialysis catheter dysfunction
3. 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. 4.ultimately enhance patient's autonomy with ergonomics \& safe procedures

Conditions

Renal Disease, Chronic; Hemodialysis Catheter Infection

Keywords

Central venous catheter; UPLUG; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  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

  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

  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

  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

  Day 29, Day 57, Day 85, Day 113

Study Arms (2)

UPLUG Arm

EXPERIMENTAL

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

Device: Connecting valve system; Device: Central haemodialysis Venous Catheter

Standard Of Care Arm

OTHER

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

Device: Central haemodialysis Venous Catheter

Interventions

Connecting valve system 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

Also known as: UPLUG Port, UPLUG Disposable

UPLUG Arm

Central haemodialysis Venous Catheter 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; UPLUG Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Life expectancy \< 1 year
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Tenon, service de Néphrologie

Paris, 75020, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Infections

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hafedh FESSI, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Dominique JOLY, PUPH

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centered open labelled two-arm randomized (1:1) superiority trial. One arm will have standard dialysis, the other arm will have dialysis using the UPLUG device

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 4, 2023
• Study Start: October 16, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

FR (1)