xml: <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/NCT06005896</url>
    </required_header>
    <id_info>
      <org_study_id>51678521.0.0000.0068</org_study_id>
      <nct_id>NCT06005896</nct_id>
    </id_info>
    <brief_title>A Clinical Model for Dialysis Discontinuation in AKI</brief_title>
    <official_title>A Clinical Model to Predict Successful Renal Replacement Therapy (RRT) Discontinuation in Patients With Acute Kidney Injury (AKI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sao Paulo General Hospital</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>
        A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48&#xD;
        hours. Patients who were still RRT-independent 7 days after initial RRT cessation were&#xD;
        included in the &quot;Success&quot; group, as opposed to the &quot;Failure&quot; group. Baseline characteristics&#xD;
        and variables at the time of RRT interruption were collected. Multivariable analysis was&#xD;
        performed and a model was generated to evaluate the prediction of success.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2020</start_date>
    <completion_date type="Actual">February 1, 2022</completion_date>
    <primary_completion_date type="Actual">February 1, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Success in RRT discontinuation</measure>
      <time_frame>7 days</time_frame>
      <description>To be alive and free from RRT 7 days after interrupting RRT.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">124</enrollment>
    <condition>Acute Renal Failure</condition>
    <condition>Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>Success</arm_group_label>
      <description>Patients who were alive and free from RRT 7 days after interrupting RRT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Failure</arm_group_label>
      <description>Patients who were not alive or who needed to dialyse again after interrupting RRT for at least 48h.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill patients from a large tertiary care hospital receiving kidney replacement&#xD;
          therapy due to AKI.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients receiving kidney replacement therapy due to AKI from October 2020 to&#xD;
               February 2022 were considered for inclusion in the study. Patients who managed to&#xD;
               remain at least 48 consecutive hours without receiving kidney replacement therapy&#xD;
               prescription were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had kidney replacement therapy interrupted exclusively due to&#xD;
               haemodynamic instability, death or decision for palliative care were excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of São Paulo School of Medicine</name>
        <address>
          <city>São Paulo</city>
          <state>SP</state>
          <zip>01246903</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>Acute Kidney Injury</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005896
  org study id: 51678521.0.0000.0068
  nct id: NCT06005896
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48
        hours. Patients who were still RRT-independent 7 days after initial RRT cessation were
        included in the "Success" group, as opposed to the "Failure" group. Baseline characteristics
        and variables at the time of RRT interruption were collected. Multivariable analysis was
        performed and a model was generated to evaluate the prediction of success.
  observational model: Cohort
  time perspective: Retrospective
  measure: Success in RRT discontinuation
  time frame: 7 days
  description: To be alive and free from RRT 7 days after interrupting RRT.
  arm group label: Success
  description: Patients who were alive and free from RRT 7 days after interrupting RRT.
  arm group label: Failure
  description: Patients who were not alive or who needed to dialyse again after interrupting RRT for at least 48h.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury