<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/NCT04451018</url>
  </required_header>
  <id_info>
    <org_study_id>38RC19.285</org_study_id>
    <secondary_id>2019-A02454-53</secondary_id>
    <nct_id>NCT04451018</nct_id>
  </id_info>
  <brief_title>Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients</brief_title>
  <acronym>SYSTOE-HAIDI</acronym>
  <official_title>Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of macro and microcirculatory arterial condition of the upper limb in&#xD;
      insufficiently renal patients&#xD;
&#xD;
      Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis&#xD;
      in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the&#xD;
      functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.&#xD;
&#xD;
      In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the&#xD;
      ischemic condition appears to be rather the result of uncompensated arteriatory of the upper&#xD;
      limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without&#xD;
      validated formal criteria for arterial disease in the upper limbs, with fistula flow&#xD;
      calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can&#xD;
      also be performed. The pressures of the digital arteries are also indicated with&#xD;
      non-consensual values found in the literature for the diagnosis of digital ischemia but with&#xD;
      varying tools in terms of collection of measurements.&#xD;
&#xD;
      The main objective of this study is to collate the characteristics of arterial condition of&#xD;
      the upper limbs of medium or severe renal patients, medium- or short-term candidates for&#xD;
      kidney dialysis. The data collected will match the data of the arterial echodoppler as well&#xD;
      as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to&#xD;
      be older and polyvascular. A better assessment of the vascular condition of their upper&#xD;
      limbs, including the diagnosis of advanced arterial disease, could eventually guide the&#xD;
      choice of type of dialysis (compared to an indication of FAV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, monocentric study&#xD;
&#xD;
      The main objective of the research Description of the arterial condition of the upper limbs&#xD;
      of kidney failure patients candidates for dialysis Primary Search Judgment Criterion:&#xD;
      Description of the ultrasound characteristics of the arterial echo-doppler of the upper&#xD;
      limbs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">June 17, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 17, 2025</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>arterial condition of the upper limbs</measure>
    <time_frame>24 HOURS</time_frame>
    <description>Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Arteriopathy Upper Limb</condition>
  <condition>Renal Insufficiency</condition>
  <condition>Digital Pressure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>evaluation of arterial anomalies in upper limbs</intervention_name>
    <description>evaluation of arterial anomalies in upper limbs with doppler ultrasound</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic renal failure patient with nephrologist's decision to pre-dialysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic renal failure patient with nephrologist's decision to pre-dialysis Or Chronic&#xD;
             renal insufficient patient with arteriovenous fistula of the upper limb and sign of&#xD;
             digital ischemia (cold hand, digital ulcer, digital necrosis) Agreement on the study's&#xD;
             non-opposition form Age above or equal 18 years Patient affiliated with a social&#xD;
             security plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject under guardianship or subject deprived of liberty Failure to obtain patient's&#xD;
             consent&#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>Sophie BLAISE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophie BLAISE</last_name>
    <phone>+33(0)476 76 55 47</phone>
    <phone_ext>+33</phone_ext>
    <email>SBlaise@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatima BOUCHAFA</last_name>
    <phone>04 76 76 51 49</phone>
    <phone_ext>+33</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie G BLAISE</last_name>
      <phone>+33 (0)4 76 76 55 47</phone>
    </contact>
    <contact_backup>
      <last_name>Fatima BOUCHAFA</last_name>
      <phone>+33 (0)4 76 76 51 49</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>February 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</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/NCT04451018
org study id: 38RC19.285
secondary id: 2019-A02454-53
nct id: NCT04451018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of macro and microcirculatory arterial condition of the upper limb in
      insufficiently renal patients

      Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis
      in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the
      functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.

      In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the
      ischemic condition appears to be rather the result of uncompensated arteriatory of the upper
      limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without
      validated formal criteria for arterial disease in the upper limbs, with fistula flow
      calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can
      also be performed. The pressures of the digital arteries are also indicated with
      non-consensual values found in the literature for the diagnosis of digital ischemia but with
      varying tools in terms of collection of measurements.

      The main objective of this study is to collate the characteristics of arterial condition of
      the upper limbs of medium or severe renal patients, medium- or short-term candidates for
      kidney dialysis. The data collected will match the data of the arterial echodoppler as well
      as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to
      be older and polyvascular. A better assessment of the vascular condition of their upper
      limbs, including the diagnosis of advanced arterial disease, could eventually guide the
      choice of type of dialysis (compared to an indication of FAV).
Prospective, monocentric study

      The main objective of the research Description of the arterial condition of the upper limbs
      of kidney failure patients candidates for dialysis Primary Search Judgment Criterion:
      Description of the ultrasound characteristics of the arterial echo-doppler of the upper
      limbs.
observational model: Cohort
time perspective: Prospective
measure: arterial condition of the upper limbs
time frame: 24 HOURS
description: Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries
intervention type: Other
intervention name: evaluation of arterial anomalies in upper limbs
description: evaluation of arterial anomalies in upper limbs with doppler ultrasound
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie BLAISE
role: Principal Investigator
affiliation: University Hospital, Grenoble
last name: Sophie BLAISE
phone: +33(0)476 76 55 47
phone ext: +33
email: SBlaise@chu-grenoble.fr
last name: Fatima BOUCHAFA
phone: 04 76 76 51 49
phone ext: +33
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No