Renal Disease, ChronicUPLUG-EVIDENCENCT05670964
Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis
A study testing Connecting valve system and Central haemodialysis Venous Catheter in people with Renal Disease, Chronic and Hemodialysis Catheter Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease, Chronic, Hemodialysis Catheter Infection
- What is being tested?
- Connecting valve system and Central haemodialysis Venous Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease
- Chronic haemodialysis
- indwelling de novo or replacement central veinous catheter
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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
- Being tested
- Connecting valve system, Central haemodialysis Venous Catheter
- Keywords
- Central venous catheter, UPLUG, Infection
- Medical subject headings
- Renal Insufficiency, Chronic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecting valve systemDevice
Also called UPLUG Port, UPLUG Disposable
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 CatheterDevice
Central haemodialysis venous catheter (CE marked) will be used within the scope of their intended purpose during the dialysis session
| Study group | Role | What they receive |
|---|---|---|
| UPLUG Arm | Experimental | Patients will have regular central veinous catheter and UPLUG device for their dialysis sessions. Receives: 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. Receives: Device: Central haemodialysis Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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"
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Day 29, Day 57, Day 85, 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1, Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start16 Oct 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: liquidation of the compagny
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafedh FESSI, PH, Principal investigator, Assistance Publique - Hôpitaux de ParisDominique JOLY, PUPH, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670964
- Sponsor's protocol ID
- APHP211510
- Acronym
- UPLUG-EVIDENCE
- Status last verified
- May 2024
- First submitted
- 9 Dec 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuation of the Impact of the UPLUG DEvice Onto the iNfection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic hEmodialysis
- ClinicalTrials.gov ID
- NCT05670964
- Acronym / sponsor ID
- UPLUG-EVIDENCE / APHP211510
- Keywords
- Central venous catheter, UPLUG, Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: liquidation of the compagny
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| UPLUG Arm | Experimental | Device: Connecting valve system, Device: Central haemodialysis Venous CatheterPatients will have regular central veinous catheter and UPLUG device for their dialysis sessions. |
| Standard Of Care Arm | Other | Device: Central haemodialysis Venous CatheterPatients will have regular central veinous catheter (standard of care) for their dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End-stage renal disease
- Chronic haemodialysis
- indwelling de novo or replacement central veinous catheter
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connecting valve systemAlso: UPLUG Port, UPLUG DisposableUPLUG 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 | UPLUG Arm |
| Central haemodialysis Venous CatheterCentral haemodialysis venous catheter (CE marked) will be used within the scope of their intended purpose during the dialysis session | Device | Standard Of Care Arm, UPLUG Arm |
Primary outcome
Number of bacterial infection within the 16 weeks of treatment period
Time frame: 16 weeks
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
11 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 29, Day 57, Day 85, Day 113
The patient satisfaction
Time frame: 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
Time frame: Day 29, Day 57, Day 85, Day 113
Rate of infections other than bacterial evaluated at Day 29, Day 57, Day 85 and Day 113
Time frame: Day 29, Day 57, Day 85, Day 113
Rate of unplanned hospitalisation at Day 113 and at the end of the study
Time frame: 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
Time frame: Day 1, Day 29, Day 57, Day 85, Day 113
The nurse satisfaction for the patients in UPLUG arm
Time frame: Day 1, Day 113
Results and safety
The study was stopped early (reason given: liquidation of the compagny). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafedh FESSI, PH principal investigator
Assistance Publique - Hôpitaux de Paris
Dominique JOLY, PUPH study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connecting valve system and Central haemodialysis Venous Catheter in people with Renal Disease, Chronic and Hemodialysis Catheter Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: liquidation of the compagny). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bacterial infection within the 16 weeks of treatment period (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.