<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/NCT02264964</url>
  </required_header>
  <id_info>
    <org_study_id>CZHKI-HDVA-002</org_study_id>
    <nct_id>NCT02264964</nct_id>
  </id_info>
  <brief_title>Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis</brief_title>
  <acronym>DACAPO</acronym>
  <official_title>Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Haidian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Changzheng Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be&#xD;
      investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal&#xD;
      failure requiring hemodialysis will be enrolled. 900 patients will be given right internal&#xD;
      jugular catheterization, and the other 500 patients unsuitable for right internal jugular&#xD;
      catheterization will receive femoral catheterizations. Every patient will be followed-up for&#xD;
      six months. During following-up period, the duration time and adverse events of non-cuffed&#xD;
      catheter will be recorded in details, including inadequate hemodialysis blood flow, venous&#xD;
      stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will&#xD;
      be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This&#xD;
      multicentre trial will provide evidence to develop guideline for duration time of using&#xD;
      non-cuffed catheter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bloodstream infection due to central venous catheter</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central venous catheter exit site infection</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inadequate hemodialysis blood flow</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central venous catheter thrombosis</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>venous thrombosis</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>venous stenosis</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration time of non-cuff catheter</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long term occurrence of venous stenosis</measure>
    <time_frame>6 months</time_frame>
    <description>CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on ECG</measure>
    <time_frame>From baseline to 6months</time_frame>
    <description>ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Evaluation</measure>
    <time_frame>From baseline to 6months</time_frame>
    <description>adverse event or serious adverse event</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Renal Failure Chronic Requiring Hemodialysis</condition>
  <condition>Central Venous Catheterization</condition>
  <condition>Inadequate Hemodialysis Blood Flow</condition>
  <condition>Venous Stenosis</condition>
  <condition>Venous Thrombosis</condition>
  <condition>Infection Due to Central Venous Catheter</condition>
  <condition>Central Venous Catheter Thrombosis</condition>
  <arm_group>
    <arm_group_label>internal jugular vein catheterization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>femoral vein catheterization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GamCath®</intervention_name>
    <description>Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.</description>
    <arm_group_label>femoral vein catheterization</arm_group_label>
    <other_name>radiopaque catheter(11F) polyurethane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arteriovenous fistula creation</intervention_name>
    <description>500 patients will undergo AVF creation in either arm for femoral vein catheterization group.</description>
    <arm_group_label>femoral vein catheterization</arm_group_label>
    <other_name>Arteriovenous fistulization</other_name>
    <other_name>AVF creation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GamCath®</intervention_name>
    <description>Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.</description>
    <arm_group_label>internal jugular vein catheterization</arm_group_label>
    <other_name>radiopaque catheter(11F) polyurethane with curved extension lines</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arteriovenous fistula creation</intervention_name>
    <description>900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.</description>
    <arm_group_label>internal jugular vein catheterization</arm_group_label>
    <other_name>Arteriovenous fistulization</other_name>
    <other_name>AVF creation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic renal failure requiring hemodialysis.&#xD;
&#xD;
          -  No medical history of central vena catheterization.&#xD;
&#xD;
          -  Maintenance hemodialysis after central vena catheterization.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had been performed central venous puncture or catheterization before.&#xD;
&#xD;
          -  Can not use heparin.&#xD;
&#xD;
          -  Refused to sign the informed consent.&#xD;
&#xD;
          -  Advanced cancer patients.&#xD;
&#xD;
          -  With or will take arteriovenous fistula surgery in right arm.&#xD;
&#xD;
          -  Other inappropriate situation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changlin Mei, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Nephrology, Shanghai ChangZheng Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yiyi Ma, master</last_name>
    <phone>+8613661679863</phone>
    <email>dukemm@126.com</email>
  </overall_contact>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Changlin Mei</investigator_full_name>
    <investigator_title>Professor, Director, Division of Nephrology</investigator_title>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>End-Stage Kidney Disease</keyword>
  <keyword>Central Venous Catheterization</keyword>
  <keyword>Digital Subtraction Angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Upper Extremity Deep Vein Thrombosis</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/NCT02264964
org study id: CZHKI-HDVA-002
nct id: NCT02264964
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be
      investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal
      failure requiring hemodialysis will be enrolled. 900 patients will be given right internal
      jugular catheterization, and the other 500 patients unsuitable for right internal jugular
      catheterization will receive femoral catheterizations. Every patient will be followed-up for
      six months. During following-up period, the duration time and adverse events of non-cuffed
      catheter will be recorded in details, including inadequate hemodialysis blood flow, venous
      stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will
      be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This
      multicentre trial will provide evidence to develop guideline for duration time of using
      non-cuffed catheter.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Bloodstream infection due to central venous catheter
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: Central venous catheter exit site infection
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: Inadequate hemodialysis blood flow
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: Central venous catheter thrombosis
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: venous thrombosis
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: venous stenosis
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: Duration time of non-cuff catheter
time frame: up to 3 months
description: Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
measure: Long term occurrence of venous stenosis
time frame: 6 months
description: CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.
measure: Effects on ECG
time frame: From baseline to 6months
description: ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
measure: Safety Evaluation
time frame: From baseline to 6months
description: adverse event or serious adverse event
arm group label: internal jugular vein catheterization
arm group type: Experimental
description: 900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.
arm group label: femoral vein catheterization
arm group type: Experimental
description: 500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation.
intervention type: Device
intervention name: GamCath®
description: Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
arm group label: femoral vein catheterization
other name: radiopaque catheter(11F) polyurethane
intervention type: Procedure
intervention name: Arteriovenous fistula creation
description: 500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
arm group label: femoral vein catheterization
other name: Arteriovenous fistulization
other name: AVF creation
intervention type: Device
intervention name: GamCath®
description: Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
arm group label: internal jugular vein catheterization
other name: radiopaque catheter(11F) polyurethane with curved extension lines
intervention type: Procedure
intervention name: Arteriovenous fistula creation
description: 900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
arm group label: internal jugular vein catheterization
other name: Arteriovenous fistulization
other name: AVF creation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Changlin Mei, master
role: Principal Investigator
affiliation: Division of Nephrology, Shanghai ChangZheng Hospital
last name: Yiyi Ma, master
phone: +8613661679863
email: dukemm@126.com
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Changlin Mei
investigator title: Professor, Director, Division of Nephrology
mesh term: Kidney Failure, Chronic
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Upper Extremity Deep Vein Thrombosis