search
Back to results

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

Primary Purpose

Renal Disease, Chronic, Hemodialysis Catheter Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Connecting valve system
Central haemodialysis Venous Catheter
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Disease, Chronic focused on measuring Central venous catheter, UPLUG, Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Tenon, service de NéphrologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

UPLUG Arm

Standard Of Care Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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"
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
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
The patient satisfaction
Patient satisfaction is assessed through : a specific UBIPLUG questionnaire and a questionnaire SF-36 (Short-Form 36 Health Survey)
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
Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113
infections other than bacterial : viral, fungal, parasitic
Rate of unplanned hospitalisation at Day 113 and at the end of the study
Unplanned hospitalisation including less than 12 hours
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
The nurse satisfaction for the patients in UPLUG arm
Assessed through a specific UBIPLUG questionnaire

Full Information

First Posted
December 9, 2022
Last Updated
October 23, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05670964
Brief Title
Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis
Acronym
UPLUG-EVIDENCE
Official Title
EValuation of the Impact of the UPLUG DEvice Onto the iNfection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic hEmodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 : reduce the haemodialysis catheter openings, hence potentially reducing the infectious risk, improve the lock solution infusion using a positive pressure, limiting the thrombosis risk and associated haemodialysis catheter dysfunction 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 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 : 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease, Chronic, Hemodialysis Catheter Infection
Keywords
Central venous catheter, UPLUG, Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
464 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UPLUG Arm
Arm Type
Experimental
Arm Description
Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions.
Arm Title
Standard Of Care Arm
Arm Type
Other
Arm Description
Patients will have regular central veinous catheter (standard of care) for their dialysis.
Intervention Type
Device
Intervention Name(s)
Connecting valve system
Other Intervention Name(s)
UPLUG Port, UPLUG Disposable
Intervention Description
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
Intervention Name(s)
Central haemodialysis Venous Catheter
Intervention Description
Central haemodialysis venous catheter (CE marked) will be used within the scope of their intended purpose during the dialysis session
Primary Outcome Measure Information:
Title
Number of bacterial infection within the 16 weeks of treatment period
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Day 29, Day 57, Day 85 and Day 113
Title
Number of positive blood culture during the 16 weeks of the treatment period evaluated at Day 29, Day 57, Day 85 and Day 113
Description
Positive blood culture from one of the following : 1/ HD catheter Or 2/ Peripheral vein Or 3/ Dialysis bloodline
Time Frame
Day 29, Day 57, Day 85 and Day 113
Title
Number of dysfunction estimated by blood flow rate (Qb) evaluated at Day 29, Day 57, Day 85 and Day 113
Description
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"
Time Frame
Day 29, Day 57, Day 85 and Day 113
Title
Number of adverse events during the 16 weeks of treatment period evaluated at D29, D57, D85 and D113
Description
Adverse events defined as defectiveness of the device, defectiveness of the placement, thrombosis events and infections
Time Frame
D29, D57, D85 and D113
Title
Number of infections other than bacterial during the 16 weeks of treatment period evaluated at Day 29, Day 57, Day 85 and Day 113
Description
Infections other than bacterial : viral, fungal, parasitic
Time Frame
Day 29, Day 57, Day 85, Day 113
Title
The patient satisfaction
Description
Patient satisfaction is assessed through : a specific UBIPLUG questionnaire and a questionnaire SF-36 (Short-Form 36 Health Survey)
Time Frame
Day 1, Day 29, Day 57, Day 85, Day 113, Day 141
Title
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
Description
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
Time Frame
Day 29, Day 57, Day 85, Day 113
Title
Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113
Description
infections other than bacterial : viral, fungal, parasitic
Time Frame
Day 29, Day 57, Day 85, Day 113
Title
Rate of unplanned hospitalisation at Day 113 and at the end of the study
Description
Unplanned hospitalisation including less than 12 hours
Time Frame
Day 113, Day 141
Title
Time spent by session by the nurse to connect the patient at Day 1, Day 29, Day 57, Day 85 and Day 113
Description
Measured time from the start of the catheter management to the start of the dialysis session
Time Frame
Day 1, Day 29, Day 57, Day 85, Day 113
Title
The nurse satisfaction for the patients in UPLUG arm
Description
Assessed through a specific UBIPLUG questionnaire
Time Frame
Day 1, Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafedh FESSI, PH
Phone
0156016029
Ext
+33
Email
hafedh.fessi@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique JOLY, PUPH
Phone
0144495412
Ext
+33
Email
dominique.joly@nck.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafedh FESSI, PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique JOLY, PUPH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Tenon, service de Néphrologie
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafedh FESSI, PH
Email
hafedh.fessi@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Antoine MICHEL, PH
Email
pierre-antoine.michel@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs