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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Catheter-related bloodstream infection [ Time Frame: through study completion, an average of 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Catheter-related Bloodstream Infection
Intervention  ICMJE
  • Device: High-Flow Needleless Valve
  • Device: DualCap Disinfection Devices
Study Arms  ICMJE
  • 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
    Intervention: 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
    Interventions:
    • Device: High-Flow Needleless Valve
    • Device: DualCap Disinfection Devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990923
Other Study ID Numbers  ICMJE PekingHDNC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rong Xu, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University First Hospital
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP