<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/NCT04416971</url>
  </required_header>
  <id_info>
    <org_study_id>Mature Fistulas</org_study_id>
    <nct_id>NCT04416971</nct_id>
  </id_info>
  <brief_title>Clinical Values of Mature Fistulas in Hemodialysis</brief_title>
  <official_title>Clinical Values of Mature Fistulas in Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and&#xD;
      fistula-first is the general recommendation for all HD patients. But in clinical practice in&#xD;
      China, quite a few patients start HD before AVF maturation due to various situations. Whether&#xD;
      HD initiation with mature AVF will influence the patency and complications is controversial.&#xD;
      This study is aim to compare the AVF patency in incident HD patients with mature or immature&#xD;
      AVF on HD initiation, and to compare other clinical outcomes, including abandonment without&#xD;
      use, infection, and other AVF complications occurrence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 20, 2020</start_date>
  <completion_date type="Anticipated">November 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AVF patency</measure>
    <time_frame>June 2020 to June 2021</time_frame>
    <description>A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abandonment without use, infection, and other complications of AVF creation.</measure>
    <time_frame>June 2020 to June 2021</time_frame>
    <description>Abandonment without use, infection, and other complications of AVF creation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hemodialysis Access Failure</condition>
  <condition>Hemodialysis Complication</condition>
  <arm_group>
    <arm_group_label>mature AVF</arm_group_label>
    <description>Patients initiate HD with mature AVF.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>immature AVF</arm_group_label>
    <description>Patients initiate HD with immature AVF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AVF puncture</intervention_name>
    <description>For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.</description>
    <arm_group_label>immature AVF</arm_group_label>
    <arm_group_label>mature AVF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  aged 18 years and older&#xD;
&#xD;
          -  underwent initial upper-extremity AVF creation for incident HD at our hospital&#xD;
&#xD;
          -  divided into mature/immature AVF groups according to the AVF status on HD initiation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  underwent initial upper-extremity AVF creation for incident HD at Zhongshan Hospital,&#xD;
             Fudan University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with malignancies&#xD;
&#xD;
          -  not followed-up at Zhongshan Hospital, Fudan University&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>bo shen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>bo shen, MD</last_name>
    <phone>+86-13795307471</phone>
    <email>shen.bo@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>No.180, Fenglin Road, Xuhui District</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wenlv lv, MD</last_name>
      <email>lv.wenlv@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Bo Shen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04416971
org study id: Mature Fistulas
nct id: NCT04416971
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and
      fistula-first is the general recommendation for all HD patients. But in clinical practice in
      China, quite a few patients start HD before AVF maturation due to various situations. Whether
      HD initiation with mature AVF will influence the patency and complications is controversial.
      This study is aim to compare the AVF patency in incident HD patients with mature or immature
      AVF on HD initiation, and to compare other clinical outcomes, including abandonment without
      use, infection, and other AVF complications occurrence.
observational model: Cohort
time perspective: Prospective
measure: AVF patency
time frame: June 2020 to June 2021
description: A functional AVF was defined as allowing at least six adequate HD sessions without any AVF-related complications. Primary AVF patency was defined as the interval from HD initiation via a functional AVF to any intervention designed for maintenance or reestablishment of AVF function, AVF failure, or study end, whichever occurred first, and secondary AVF patency was defined as the interval from HD initiation via an AVF until the termination of HD via AVF due to any cause, regardless of the number of subsequent interventions.
measure: Abandonment without use, infection, and other complications of AVF creation.
time frame: June 2020 to June 2021
description: Abandonment without use, infection, and other complications of AVF creation.
arm group label: mature AVF
description: Patients initiate HD with mature AVF.
arm group label: immature AVF
description: Patients initiate HD with immature AVF.
intervention type: Procedure
intervention name: AVF puncture
description: For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.
arm group label: immature AVF
arm group label: mature AVF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: bo shen, MD
role: Principal Investigator
affiliation: Fudan University
last name: bo shen, MD
phone: +86-13795307471
email: shen.bo@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Bo Shen
investigator title: Principal Investigator
mesh term: Fistula
sharing ipd: No