Catheter-related Bloodstream InfectionPhase 4NCT02990923
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
A Phase 4 study testing High-Flow Needleless Valve and DualCap Disinfection Devices in people with Catheter-related Bloodstream Infection, run by Peking University First Hospital.
Trial summary
The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-related Bloodstream Infection
- What is being tested?
- High-Flow Needleless Valve and DualCap Disinfection Devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Feb 2018
- Phase
- Phase 4
- 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
- Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
- Have signed information consent form
Who cannot join
- Have got bacteremia before catheter implantation
- Catheter changing in situ
About this study
Official title: The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial
The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.
- Conditions
- Catheter-related Bloodstream Infection
- Being tested
- High-Flow Needleless Valve, DualCap Disinfection Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Needleless ValveDevice
DualCap Disinfection DevicesDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management |
| Only High-Flow Valve | Experimental | In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management Receives: Device: High-Flow Needleless Valve |
| Both Divices | Experimental | In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis Receives: Device: High-Flow Needleless Valve; Device: DualCap Disinfection Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related bloodstream infection
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Number of participants with catheter withdraw for any reason
Measured: through study completion, an average of 1 year
Number of participants with catheter dysfunction
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-related Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Xu, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990923
- Sponsor's protocol ID
- PekingHDNC
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02990923
- Acronym / sponsor ID
- PekingHDNC
- Conditions
- Catheter-related Bloodstream Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Feb 2018 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management |
| Only High-Flow Valve | Experimental | Device: High-Flow Needleless ValveIn this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management |
| Both Divices | Experimental | Device: High-Flow Needleless Valve, Device: DualCap Disinfection DevicesIn this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
- Have signed information consent form
Key exclusion criteria (2 listed)
- Have got bacteremia before catheter implantation
- Catheter changing in situ
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 |
|---|---|---|
| High-Flow Needleless Valve | Device | Both Divices, Only High-Flow Valve |
| DualCap Disinfection Devices | Device | Both Divices |
Primary outcome
Catheter-related bloodstream infection
Time frame: through study completion, an average of 1 year
2 secondary outcomes
Number of participants with catheter withdraw for any reason
Time frame: through study completion, an average of 1 year
Number of participants with catheter dysfunction
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-Flow Needleless Valve and DualCap Disinfection Devices in people with Catheter-related Bloodstream Infection, run by Peking University First Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Catheter-related bloodstream infection (time frame: through study completion, an average of 1 year). 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 13 Dec 2016.