Back to resultsHigh-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
Primary Purpose
Catheter-related Bloodstream Infection
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
High-Flow Needleless Valve
DualCap Disinfection Devices
Sponsored by
About this trial
This is an interventional prevention trial for Catheter-related Bloodstream Infection
Eligibility Criteria
Inclusion Criteria:
- Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
- Have signed information consent form
Exclusion Criteria:
- Have got bacteremia before catheter implantation
- Catheter changing in situ
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Only High-Flow Valve
Both Divices
Arm Description
In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management
In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management
In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis
Outcomes
Primary Outcome Measures
Catheter-related bloodstream infection
Secondary Outcome Measures
Number of participants with catheter withdraw for any reason
Number of participants with catheter dysfunction
Full Information
NCT ID
NCT02990923
First Posted
December 2, 2016
Last Updated
December 12, 2016
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02990923
Brief Title
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-related Bloodstream Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management
Arm Title
Only High-Flow Valve
Arm Type
Experimental
Arm Description
In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management
Arm Title
Both Divices
Arm Type
Experimental
Arm Description
In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis
Intervention Type
Device
Intervention Name(s)
High-Flow Needleless Valve
Intervention Type
Device
Intervention Name(s)
DualCap Disinfection Devices
Primary Outcome Measure Information:
Title
Catheter-related bloodstream infection
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of participants with catheter withdraw for any reason
Time Frame
through study completion, an average of 1 year
Title
Number of participants with catheter dysfunction
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
Have signed information consent form
Exclusion Criteria:
Have got bacteremia before catheter implantation
Catheter changing in situ
12. IPD Sharing Statement
Learn more about this trial
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
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