<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/NCT04459975</url>
  </required_header>
  <id_info>
    <org_study_id>CoV-AKI_2020</org_study_id>
    <nct_id>NCT04459975</nct_id>
  </id_info>
  <brief_title>Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units</brief_title>
  <official_title>Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute&#xD;
      respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has&#xD;
      appeared to be more frequent and more severe than expected. Some data suggested a potential&#xD;
      direct renal tropism of the virus, or undirect injury by &quot;cytokine storm&quot;.&#xD;
&#xD;
      The aims of this study are:&#xD;
&#xD;
        1. To describe incidence, severity and mortality associated with AKI during covid-19&#xD;
           infection in ICU&#xD;
&#xD;
        2. To identify specific risk factors for AKI&#xD;
&#xD;
        3. To explore pathophysiologic mechanism of AKI during COVID-19 infection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection</measure>
    <time_frame>7 months</time_frame>
    <description>AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>on Occurrence of Acurate Kidney Injury During Intensive Care Unit</condition>
  <condition>Abnormalities of Urinary Analysis</condition>
  <arm_group>
    <arm_group_label>AKI (-)</arm_group_label>
    <description>patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine &gt; 1,5x baseline according with KDIGO guidelines)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AKI (+)</arm_group_label>
    <description>patient treated in ICU for COVID-19 infection and with occurrence of AKI among which:&#xD;
• Severe AKI patients (define as creatinine &gt; 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non interventional study</intervention_name>
    <description>Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient.&#xD;
Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis</description>
    <arm_group_label>AKI (+)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients supported in intensive care units for covid-19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 infection (by qRT-PCR and/or TDM typical lesion)&#xD;
&#xD;
          -  Needing intensive care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End Stage Renal Disease patients (with pre-existent dialysis)&#xD;
&#xD;
          -  Intensive care support for less than 72h (transfer in conventional unit or death)&#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_contact>
    <last_name>Denis FOUQUE, Professor</last_name>
    <phone>+33 472 678 704</phone>
    <email>denis.fouque@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maxime ESPI</last_name>
    <phone>+33 472 678 704</phone>
    <email>maxime.espi@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intensive care units attached to the Hospices Civils de Lyon (HCL)</name>
      <address>
        <city>Lyon</city>
        <zip>69002</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis FOUQUE, Professor</last_name>
      <phone>+33 472 678 704</phone>
      <email>denis.fouque@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Maxime EPSI</last_name>
      <phone>+33 472 678 704</phone>
      <email>maxime.espi@chu-lyon.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acurate Kidney Injury</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>
  <!-- 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/NCT04459975
org study id: CoV-AKI_2020
nct id: NCT04459975
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute
      respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has
      appeared to be more frequent and more severe than expected. Some data suggested a potential
      direct renal tropism of the virus, or undirect injury by "cytokine storm".

      The aims of this study are:

        1. To describe incidence, severity and mortality associated with AKI during covid-19
           infection in ICU

        2. To identify specific risk factors for AKI

        3. To explore pathophysiologic mechanism of AKI during COVID-19 infection
observational model: Cohort
time perspective: Retrospective
measure: Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection
time frame: 7 months
description: AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h
arm group label: AKI (-)
description: patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine > 1,5x baseline according with KDIGO guidelines)
arm group label: AKI (+)
description: patient treated in ICU for COVID-19 infection and with occurrence of AKI among which:
• Severe AKI patients (define as creatinine > 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death).
intervention type: Other
intervention name: Non interventional study
description: Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient.
Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis
arm group label: AKI (+)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Denis FOUQUE, Professor
phone: +33 472 678 704
email: denis.fouque@chu-lyon.fr
last name: Maxime ESPI
phone: +33 472 678 704
email: maxime.espi@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries