<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/NCT04418726</url>
  </required_header>
  <id_info>
    <org_study_id>AVF-assessment</org_study_id>
    <nct_id>NCT04418726</nct_id>
  </id_info>
  <brief_title>Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF</brief_title>
  <official_title>The Clinical Value of Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF: a Random Controlled Trial</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>
      Whether intensive monitoring and preemptive intervention has an positive clinical effect on&#xD;
      arterio-venous fistula (AVF) maintenance is a new issue in hemodialysis (HD) patient&#xD;
      management. This study aims to explore the clinical value of intensive monitoring and&#xD;
      preemptive intervention on AVF, so to decide the best follow-up items and frequency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AVF patency rate</measure>
    <time_frame>6 months</time_frame>
    <description>AVF patency rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AVF complication</measure>
    <time_frame>12 months</time_frame>
    <description>AVF complication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Vascular Access Malfunction</condition>
  <condition>Vascular Access Complication</condition>
  <condition>Vascular Access Site Occlusion</condition>
  <arm_group>
    <arm_group_label>Intensive Monitoring and Preemptive Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group patients receive intensive monitoring and preemptive intervention. AVF surveillance refers to using non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa every month. Clinical assessment refers to monitoring for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V. Preemptive intervention is performed as long as problems are recognized, including health education and timely surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Monitoring and Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group patient receive traditional AVF monitoring, includes clinical assessment for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensified Monitoring</intervention_name>
    <description>Apart from clinical assessment, use non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa, using either indicator dilution techniques or duplex ultrasound every month.</description>
    <arm_group_label>Intensive Monitoring and Preemptive Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients on HD with AVF in Zhongshan Hospital, Fudan University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 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>Attending Physician</investigator_title>
  </responsible_party>
  <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/NCT04418726
org study id: AVF-assessment
nct id: NCT04418726
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Whether intensive monitoring and preemptive intervention has an positive clinical effect on
      arterio-venous fistula (AVF) maintenance is a new issue in hemodialysis (HD) patient
      management. This study aims to explore the clinical value of intensive monitoring and
      preemptive intervention on AVF, so to decide the best follow-up items and frequency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: AVF patency rate
time frame: 6 months
description: AVF patency rate
measure: AVF complication
time frame: 12 months
description: AVF complication
arm group label: Intensive Monitoring and Preemptive Intervention
arm group type: Experimental
description: In this group patients receive intensive monitoring and preemptive intervention. AVF surveillance refers to using non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa every month. Clinical assessment refers to monitoring for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V. Preemptive intervention is performed as long as problems are recognized, including health education and timely surgery.
arm group label: Traditional Monitoring and Intervention
arm group type: No Intervention
description: In this group patient receive traditional AVF monitoring, includes clinical assessment for any presence of stenosis by (i) physical examination, by means of visual inspection and presence of abnormal thrill, bruit or pulse and (ii) checking for signs of access dysfunction during dialysis: difficult cannulation, increase in dynamic arterial or venous pressure, inability to achieve the prescribed dialysis blood pump flow (Qb), prolonged bleeding after needle removal, access recirculation or a drop in Kt/V.
intervention type: Other
intervention name: Intensified Monitoring
description: Apart from clinical assessment, use non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa, using either indicator dilution techniques or duplex ultrasound every month.
arm group label: Intensive Monitoring and Preemptive Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Bo Shen
investigator title: Attending Physician
sharing ipd: No