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/NCT06040736</url>
    </required_header>
    <id_info>
      <org_study_id>RECHMPL21_0158</org_study_id>
      <nct_id>NCT06040736</nct_id>
    </id_info>
    <brief_title>Point-of-care Ultrasound to Assess Hydronephrosis in Patients With Acute Kidney Injury in the Emergency Department</brief_title>
    <official_title>Point-of-care Ultrasound to Assess Hydronephrosis in Patients Presenting With Acute Kidney Injury in the Emergency Department: a Prospective Comparative Pragmatic Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Montpellier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Montpellier</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>
        Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary&#xD;
        tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic&#xD;
        management. This observational study aims at assessing the accuracy of point-of-care&#xD;
        ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation&#xD;
        or distension of the kidney secondary to urinary tract obstruction, in emergency department&#xD;
        patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS&#xD;
        of the urinary tract by the EP followed by central imaging evaluation by a radiologist&#xD;
        (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both&#xD;
        diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably&#xD;
        diagnose renal tract obstruction at POCUS in the context of AKI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary&#xD;
        tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic&#xD;
        management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary&#xD;
        tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment&#xD;
        of the renal tract and detection of hydronephrosis is a core component of the emergency&#xD;
        medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is&#xD;
        to compare the performance of point-of-care ultrasound performed by the emergency physician&#xD;
        to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis&#xD;
        in patients presenting with AKI in the ED. All imaging exams will be performed as part of&#xD;
        routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging&#xD;
        results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 2, 2020</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Performance of POCUS for the diagnosis of hydronephrosis</measure>
      <time_frame>1 day (ED length of stay)</time_frame>
      <description>Performance of POCUS for the detection of hydronephrosis compared to radiology imaging as the gold standard (sensitivity, specificity, NPV, PPV)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis</measure>
      <time_frame>1 day (ED length of stay)</time_frame>
      <description>Agreement between Pocus and radiology examination (radiology US or CT) for the diagnosis of hydronephrosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Risk Factors for POCUS misdiagnosis</measure>
      <time_frame>1 day (ED length of stay)</time_frame>
      <description>Factors associated with misdiagnosis of hydronephrosis at POCUS</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">156</enrollment>
    <condition>Acute Kidney Injury</condition>
    <condition>Urinary Tract Obstruction</condition>
    <arm_group>
      <arm_group_label>Patients with acute kidney injury</arm_group_label>
      <description>Emergency department patients presenting with acute kidney injury, regardless of their complaint for ED admission. AKI is defined based on increase in serum creatinine (SCr) levels according to Kdigo criteria Patients will undergo both a bedside point of care ultrasonography and a central radiology imaging evaluation of hydronephrosis as part of routine care</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients admitted to the emergency department of Montpellier university hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with acute kidney injury defined by changes in serum creatinine (sCr) level&#xD;
               between the index sCr at ED admission and pre and/or post sCr controls (KDiGO&#xD;
               criteria)&#xD;
  &#xD;
            -  Patient who does not oppose to the use of their data&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vesical globe&#xD;
  &#xD;
            -  Polycystic kidney disease&#xD;
  &#xD;
            -  Known renal tumor&#xD;
  &#xD;
            -  Horseshoe kidney&#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>Mustapha SEBBANE, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Montpellier</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mustapha SEBBANE, MD, PhD</last_name>
      <phone>+33 (4) 67 33 79 74</phone>
      <email>m-sebbane@chu-montpellier.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sophie LEFEBVRE, PhD</last_name>
      <phone>+33 (4) 67 33 85 76</phone>
      <email>s-lefebvre@chu-montpellier.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>university hospital of Montpellier</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Point-of-care ultrasound</keyword>
    <keyword>Acute kidney injury</keyword>
    <keyword>Hydronephrosis</keyword>
    <keyword>urinary tract obstruction</keyword>
    <keyword>Emergency Medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Hydronephrosis</mesh_term>
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06040736
  org study id: RECHMPL21_0158
  nct id: NCT06040736
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary
        tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic
        management. This observational study aims at assessing the accuracy of point-of-care
        ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation
        or distension of the kidney secondary to urinary tract obstruction, in emergency department
        patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS
        of the urinary tract by the EP followed by central imaging evaluation by a radiologist
        (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both
        diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably
        diagnose renal tract obstruction at POCUS in the context of AKI.
  Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary
        tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic
        management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary
        tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment
        of the renal tract and detection of hydronephrosis is a core component of the emergency
        medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is
        to compare the performance of point-of-care ultrasound performed by the emergency physician
        to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis
        in patients presenting with AKI in the ED. All imaging exams will be performed as part of
        routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging
        results.
  observational model: Cohort
  time perspective: Prospective
  measure: Performance of POCUS for the diagnosis of hydronephrosis
  time frame: 1 day (ED length of stay)
  description: Performance of POCUS for the detection of hydronephrosis compared to radiology imaging as the gold standard (sensitivity, specificity, NPV, PPV)
  measure: Level of agreement between ED Pocus and central radiology imaging for the diagnosis of hydronephrosis
  time frame: 1 day (ED length of stay)
  description: Agreement between Pocus and radiology examination (radiology US or CT) for the diagnosis of hydronephrosis
  measure: Risk Factors for POCUS misdiagnosis
  time frame: 1 day (ED length of stay)
  description: Factors associated with misdiagnosis of hydronephrosis at POCUS
  arm group label: Patients with acute kidney injury
  description: Emergency department patients presenting with acute kidney injury, regardless of their complaint for ED admission. AKI is defined based on increase in serum creatinine (SCr) levels according to Kdigo criteria Patients will undergo both a bedside point of care ultrasonography and a central radiology imaging evaluation of hydronephrosis as part of routine care
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mustapha SEBBANE, MD, PhD
  role: Principal Investigator
  affiliation: University Hospital, Montpellier
  last name: Mustapha SEBBANE, MD, PhD
  phone: +33 (4) 67 33 79 74
  email: m-sebbane@chu-montpellier.fr
  last name: Sophie LEFEBVRE, PhD
  phone: +33 (4) 67 33 85 76
  email: s-lefebvre@chu-montpellier.fr
  facility: 
  status: Recruiting
  country: France
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Hydronephrosis
  mesh term: Emergencies
  mesh term: Wounds and Injuries