<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/NCT03764358</url>
  </required_header>
  <id_info>
    <org_study_id>AUSTRIA</org_study_id>
    <nct_id>NCT03764358</nct_id>
  </id_info>
  <brief_title>AUSTrian Randomized Interventional Study on Dialysis Accesses</brief_title>
  <acronym>AUSTRIA</acronym>
  <official_title>Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a&#xD;
      well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a&#xD;
      &quot;fistula first&quot; approach for every patient, whenever possible. Thus, every patient,&#xD;
      regardless of age, clinical state and co-morbidities an arteriovenous fistula should be&#xD;
      preferred over a tunneled cuffed catheter (TCC). These recommendations are based on&#xD;
      retrospective and register studies. There have been no prospective studies in this subject so&#xD;
      far. In addition, most of the collected data refers to patients of all ages, regardless of&#xD;
      their comorbidities and general clinical state. In this study, we address differences between&#xD;
      two dialysis vascular access types in elderly or frail patients. We will compare TCCs with&#xD;
      arteriovenous fistulas in the selected population consisting of elderly patients over 60&#xD;
      years of age or those with a Charlson Comorbidity Index &gt;6 independent of age. In our&#xD;
      hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the&#xD;
      examined end-points.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 6, 2019</start_date>
  <completion_date type="Anticipated">October 4, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 4, 2022</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite primary end-point of any access related complication</measure>
    <time_frame>From placement of vascular access through study completion, an average of 3 years.</time_frame>
    <description>Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Catheter Infection</condition>
  <condition>Shunt Malfunction</condition>
  <arm_group>
    <arm_group_label>Arteriovenous fistula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tunneled Cuffed Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arteriovenous Fistula</intervention_name>
    <description>Surgical implantation of an arteriovenous fistula for hemodialysis</description>
    <arm_group_label>Arteriovenous fistula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tunneled Cuffed Catheter</intervention_name>
    <description>Placement of a tunneled cuffed catheter in surgical theatre</description>
    <arm_group_label>Tunneled Cuffed Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 60 and higher&#xD;
&#xD;
          -  CCI Score &gt;6 when under 60 years&#xD;
&#xD;
          -  Patients with CKD G5 A1-3 with indication for hemodialysis&#xD;
&#xD;
          -  Stable clinical condition&#xD;
&#xD;
          -  Eligibility for both arteriovenous fistula on the upper extremitiesandTCC&#xD;
&#xD;
          -  Availability for follow-up.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled infection at screening and/or CRP &gt;5 mg/dl (normal &lt;0.5 mg/dl) at&#xD;
             screening.&#xD;
&#xD;
          -  Poor general condition of health or malignancy not in remission at screening&#xD;
&#xD;
          -  Major surgery within 12 weeks before screening.&#xD;
&#xD;
          -  Pre-existent vascular access.&#xD;
&#xD;
          -  Patient not eligible for any one of the vascular access options.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guerkan Sengoelge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin Schairer, MD</last_name>
    <phone>0043 40400 43890</phone>
    <email>benjamin.schairer@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <contact>
      <last_name>Benjamin Schairer, MD</last_name>
      <phone>0043 40400</phone>
      <phone_ext>43890</phone_ext>
      <email>benjamin.schairer@meduniwien.ac.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Guerkan SENGOELGE</investigator_full_name>
    <investigator_title>Assoc. Prof. Priv.-Doz. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03764358
org study id: AUSTRIA
nct id: NCT03764358
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a
      well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a
      "fistula first" approach for every patient, whenever possible. Thus, every patient,
      regardless of age, clinical state and co-morbidities an arteriovenous fistula should be
      preferred over a tunneled cuffed catheter (TCC). These recommendations are based on
      retrospective and register studies. There have been no prospective studies in this subject so
      far. In addition, most of the collected data refers to patients of all ages, regardless of
      their comorbidities and general clinical state. In this study, we address differences between
      two dialysis vascular access types in elderly or frail patients. We will compare TCCs with
      arteriovenous fistulas in the selected population consisting of elderly patients over 60
      years of age or those with a Charlson Comorbidity Index >6 independent of age. In our
      hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the
      examined end-points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Composite primary end-point of any access related complication
time frame: From placement of vascular access through study completion, an average of 3 years.
description: Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
arm group label: Arteriovenous fistula
arm group type: Active Comparator
arm group label: Tunneled Cuffed Catheter
arm group type: Experimental
intervention type: Device
intervention name: Arteriovenous Fistula
description: Surgical implantation of an arteriovenous fistula for hemodialysis
arm group label: Arteriovenous fistula
intervention type: Device
intervention name: Tunneled Cuffed Catheter
description: Placement of a tunneled cuffed catheter in surgical theatre
arm group label: Tunneled Cuffed Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Guerkan Sengoelge, MD
role: Principal Investigator
affiliation: Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis
last name: Benjamin Schairer, MD
phone: 0043 40400 43890
email: benjamin.schairer@meduniwien.ac.at
facility: 
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Guerkan SENGOELGE
investigator title: Assoc. Prof. Priv.-Doz. Dr.
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided