<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990923</url>
  </required_header>
  <id_info>
    <org_study_id>PekingHDNC</org_study_id>
    <nct_id>NCT02990923</nct_id>
  </id_info>
  <brief_title>High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve&#xD;
      and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream&#xD;
      infection in hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Catheter-related bloodstream infection</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with catheter withdraw for any reason</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with catheter dysfunction</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Catheter-related Bloodstream Infection</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only High-Flow Valve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Both Divices</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-Flow Needleless Valve</intervention_name>
    <arm_group_label>Both Divices</arm_group_label>
    <arm_group_label>Only High-Flow Valve</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DualCap Disinfection Devices</intervention_name>
    <arm_group_label>Both Divices</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implanted non-tunneled cuff catheter for any reason and going on blood purified&#xD;
             therapy in our centre&#xD;
&#xD;
          -  Have signed information consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have got bacteremia before catheter implantation&#xD;
&#xD;
          -  Catheter changing in situ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Rong Xu</investigator_full_name>
    <investigator_title>vice professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990923
org study id: PekingHDNC
nct id: NCT02990923
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Catheter-related bloodstream infection
time frame: through study completion, an average of 1 year
measure: Number of participants with catheter withdraw for any reason
time frame: through study completion, an average of 1 year
measure: Number of participants with catheter dysfunction
time frame: through study completion, an average of 1 year
arm group label: Control
arm group type: No Intervention
description: In this group, patients will use traditional standard hemodialysis connector and receive typical disinfection management
arm group label: Only High-Flow Valve
arm group type: Experimental
description: In this group, patients will use High-Flow Needleless Valve instead of traditional standard hemodialysia connector, but still receiving typical disinfection management
arm group label: Both Divices
arm group type: Experimental
description: In this group, patients will receive both High-Flow Needleless Valve and DualCap Disinfection Devices in hemodialysis
intervention type: Device
intervention name: High-Flow Needleless Valve
arm group label: Both Divices
arm group label: Only High-Flow Valve
intervention type: Device
intervention name: DualCap Disinfection Devices
arm group label: Both Divices
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Rong Xu
investigator title: vice professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis