<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/NCT02976792</url>
  </required_header>
  <id_info>
    <org_study_id>DC 2016/94</org_study_id>
    <nct_id>NCT02976792</nct_id>
  </id_info>
  <brief_title>Effectiveness of the NephroCheck™ After TAVI</brief_title>
  <acronym>AKI-TAVI</acronym>
  <official_title>Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic&#xD;
      Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI)&#xD;
      early enough to prevent an organic dysfunction triggering, consequently, cortical tubular&#xD;
      necrosis.&#xD;
&#xD;
      Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal&#xD;
      Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly.&#xD;
      These markers, sonographic and biologic, have both the advantage to be non-invasive and easy&#xD;
      to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly&#xD;
      after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential&#xD;
      tests to guide clinicians in determining rapidly whether a patient will develop AKI after a&#xD;
      TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing&#xD;
      TAVI.&#xD;
&#xD;
      Therefore, the aim of this prospective observational study will be first to determine the&#xD;
      effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure.&#xD;
      The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an&#xD;
      earlier stage than the traditional method an AKI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Effectiveness of the NephroCheck™ test to detect AKI after TAVI</measure>
    <time_frame>Evolution of the Nephrocheck test from the time 0 to time 2.(Time 0: at inclusion before the TAVI / Time 1: NephroCheck™ Test at the first micturition post TAVI / Time 2: NephroCheck test™ on the first post operative day at the first micturition.)</time_frame>
    <description>Determine the efficacy of NephroCheck™ test to predict AKI after TAVI. AKI will be defined according to the KADIGO criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal Resistive Index compared with NephroCheck™</measure>
    <time_frame>Evolution of the Renal Resistive Index from time 0 to time 2. Time 0: at inclusion before the TAVI / Time 1: at the first micturition post TAVI/ Time 2: on the first post operative day at the first micturition.</time_frame>
    <description>compare the NephroCheck™ with the Renal Resistive Index in predicting an AKI</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Transcatheter Aortic Valve Implantation</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Postoperative Acute Renal Failure</condition>
  <arm_group>
    <arm_group_label>Renal Resistive Index/NephroCheck™test</arm_group_label>
    <description>Patients undergoing a transcatheter aortic valve implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal Resistive Index/NephroCheck™test</intervention_name>
    <description>Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI</description>
    <arm_group_label>Renal Resistive Index/NephroCheck™test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing a TAVI procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled to undergo a TAVI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic dialysis patients with anuria&#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>Alexandre OUATTARA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>head of anesthesia department II</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bordeaux</investigator_affiliation>
    <investigator_full_name>Alexandre OUATTARA</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Transcatheter aortic valve implantation</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>early acute kidney injury detection</keyword>
  <keyword>Nephrocheck™</keyword>
  <keyword>Renal Resistive Index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02976792
org study id: DC 2016/94
nct id: NCT02976792
lead sponsor: 
has dmc: No
Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic
      Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI)
      early enough to prevent an organic dysfunction triggering, consequently, cortical tubular
      necrosis.

      Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal
      Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly.
      These markers, sonographic and biologic, have both the advantage to be non-invasive and easy
      to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly
      after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential
      tests to guide clinicians in determining rapidly whether a patient will develop AKI after a
      TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing
      TAVI.

      Therefore, the aim of this prospective observational study will be first to determine the
      effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure.
      The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an
      earlier stage than the traditional method an AKI.
observational model: Cohort
time perspective: Prospective
measure: Effectiveness of the NephroCheck™ test to detect AKI after TAVI
time frame: Evolution of the Nephrocheck test from the time 0 to time 2.(Time 0: at inclusion before the TAVI / Time 1: NephroCheck™ Test at the first micturition post TAVI / Time 2: NephroCheck test™ on the first post operative day at the first micturition.)
description: Determine the efficacy of NephroCheck™ test to predict AKI after TAVI. AKI will be defined according to the KADIGO criteria.
measure: Renal Resistive Index compared with NephroCheck™
time frame: Evolution of the Renal Resistive Index from time 0 to time 2. Time 0: at inclusion before the TAVI / Time 1: at the first micturition post TAVI/ Time 2: on the first post operative day at the first micturition.
description: compare the NephroCheck™ with the Renal Resistive Index in predicting an AKI
arm group label: Renal Resistive Index/NephroCheck™test
description: Patients undergoing a transcatheter aortic valve implantation
intervention type: Procedure
intervention name: Renal Resistive Index/NephroCheck™test
description: Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI
arm group label: Renal Resistive Index/NephroCheck™test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre OUATTARA, MD, PhD
role: Principal Investigator
affiliation: head of anesthesia department II
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bordeaux
investigator full name: Alexandre OUATTARA
investigator title: MD, PhD
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No