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High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection

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ClinicalTrials.gov Identifier: NCT02990923
Recruitment Status : Unknown
Verified December 2016 by Rong Xu, Peking University First Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Rong Xu, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Catheter-related Bloodstream Infection Device: High-Flow Needleless Valve Device: DualCap Disinfection Devices Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2016
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management
Experimental: Only High-Flow Valve
In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management
Device: High-Flow Needleless Valve
Experimental: Both Divices
In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis
Device: High-Flow Needleless Valve
Device: DualCap Disinfection Devices



Primary Outcome Measures :
  1. Catheter-related bloodstream infection [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Number of participants with catheter withdraw for any reason [ Time Frame: through study completion, an average of 1 year ]
  2. Number of participants with catheter dysfunction [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Rong Xu, vice professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02990923    
Other Study ID Numbers: PekingHDNC
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Infection
Communicable Diseases