<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/NCT04470661</url>
  </required_header>
  <id_info>
    <org_study_id>GaziU-2</org_study_id>
    <nct_id>NCT04470661</nct_id>
  </id_info>
  <brief_title>Point-of-care Ultrasound for Acute Kidney Injury</brief_title>
  <official_title>Diagnostic Accuracy of Point-of-Care Ultrasound in the Etiology of Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mehmet Ali Aslaner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</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>
      It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute&#xD;
      kidney injury with POCUS performed in the emergency department. Patients who presented to the&#xD;
      emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria&#xD;
      will be evaluated and patients diagnosed with AKI will be included in the study. The&#xD;
      diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</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>The diagnostic accuracy of POCUS in the patients with AKI</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">130</enrollment>
  <condition>Acute Kidney Injury</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <description>Point-of-care ultrasound:&#xD;
Kidney length and echogenity,&#xD;
Bladder scanning&#xD;
VCI measures&#xD;
Lung B lines and effusion&#xD;
Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute kidney injury diagnosed in the ED.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • AKI diagnosis according to KDIGO criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with end stage renal failure,&#xD;
&#xD;
          -  Failure to perform POCUS in the first two hours of presentation of patient,&#xD;
&#xD;
          -  Those with renal malignancy,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Renal transplantation patients,&#xD;
&#xD;
          -  Patients with a single kidney,&#xD;
&#xD;
          -  Those with polycystic kidney disease,&#xD;
&#xD;
          -  Patients with nephrostomy,&#xD;
&#xD;
          -  Patients who are referred from another center,&#xD;
&#xD;
          -  Unable to perform adequate imaging,&#xD;
&#xD;
          -  Patients who do not give consent for the study will be 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>
  <overall_official>
    <last_name>Mehmet Aslaner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University Facaulty of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Mehmet Ali Aslaner</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <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>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/NCT04470661
org study id: GaziU-2
nct id: NCT04470661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute
      kidney injury with POCUS performed in the emergency department. Patients who presented to the
      emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria
      will be evaluated and patients diagnosed with AKI will be included in the study. The
      diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.
observational model: Cohort
time perspective: Prospective
measure: The diagnostic accuracy of POCUS in the patients with AKI
time frame: One year
intervention type: Diagnostic Test
intervention name: Ultrasonography
description: Point-of-care ultrasound:
Kidney length and echogenity,
Bladder scanning
VCI measures
Lung B lines and effusion
Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mehmet Aslaner, MD
role: Principal Investigator
affiliation: Gazi University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Gazi University
investigator full name: Mehmet Ali Aslaner
investigator title: Assoc. Prof.
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: Undecided