<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/NCT03774719</url>
  </required_header>
  <id_info>
    <org_study_id>201903192-1985080800</org_study_id>
    <nct_id>NCT03774719</nct_id>
  </id_info>
  <brief_title>Hand-carried Ultrasound to Assess Hydronephrosis</brief_title>
  <official_title>Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates if trainees can accurately rule out dilation of the renal collecting&#xD;
      system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will&#xD;
      undergo a short ultrasound training program. Patients will be adults that are hospitalized&#xD;
      and have acute or subacute kidney dysfunction. The investigators will assess sensitivity,&#xD;
      specificity, positive and negative predictive value of HCU compared to radiology performed&#xD;
      ultrasound, and calculate potential cost savings to the patient and to the healthcare system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hand-carried ultrasound is an increasingly popular imaging modality and is widely used by&#xD;
      emergency physicians, intensivists, trauma doctors and cardiologists. Renal ultrasonography&#xD;
      is commonly ordered for patients with acute kidney injury, with a main focus on identifying&#xD;
      obstruction of the collecting system, a rare but potentially reversible cause of acute kidney&#xD;
      injury.&#xD;
&#xD;
      This study's aim is to evaluate if nephrology and internal medicine trainees can accurately&#xD;
      rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using&#xD;
      hand-carried ultrasound (HCU). Trainees will undergo a short, uniform and well described&#xD;
      ultrasound training program. Patients will be adults that are hospitalized and have acute or&#xD;
      subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive&#xD;
      and negative predictive value of HCU compared to radiology performed ultrasound, and&#xD;
      calculate potential cost savings to the patient and to the healthcare system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Change in staffing, COVID, New US curriculum being developed&#xD;
  </why_stopped>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of hydronephrosis</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Direct costs of hand-carried ultrasound</measure>
    <time_frame>1 year</time_frame>
    <description>Direct costs in $ of hand-carried ultrasound will be calculated and compared to the costs of radiology performed ultrasound. For hand-carried ultrasound, this will include costs of purchasing the device, training costs, yearly depreciation of the hand-carried ultrasound device. For radiology performed ultrasound, this will include the sonographer's fee, radiologist fee for interpretation of the result, transportation fee by hospital transport and depreciation of the ultrasound machine.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ultrasound image quality</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.</description>
  </other_outcome>
  <other_outcome>
    <measure>Technical difficulty of the ultrasound study</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>How technically difficult was it for the trainees to obtain the images (patient intubated, obesity etc.) as graded by the trainees who performed the ultrasound scans themselves. Trainees will grade difficulty using the following measurement scale (1) Technically easy: trainee able to get clear images of both kidneys within a timeframe of 10 minutes (2) Technically challenging: Trainee able to get clear images of kidneys but requiring more than 10 minutes of scanning time (3) Technically difficult: trainee unable to get clear images of both kidneys independent of time spent scanning.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Hydronephrosis</condition>
  <condition>Ultrasound</condition>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Hand-carried ultrasound arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the only arm of the study. It will be comprised of 154 inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hand-carried ultrasound</intervention_name>
    <description>Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA).</description>
    <arm_group_label>Hand-carried ultrasound arm</arm_group_label>
    <other_name>Point of care ultrasound</other_name>
    <other_name>POCUS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years old&#xD;
&#xD;
          -  Inpatient admission to Barnes Jewish Hospital (BJH)&#xD;
&#xD;
          -  Patient has a diagnosis of Acute kidney injury (AKI) or Acute kidney Disease (AKD)&#xD;
&#xD;
          -  Renal ultrasound ordered or performed within the past 4 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-stage renal disease&#xD;
&#xD;
          -  History of kidney transplant&#xD;
&#xD;
          -  Stable chronic kidney disease&#xD;
&#xD;
          -  Current diagnosis of renal cell carcinoma&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Morbid obesity (BMI &gt;40)&#xD;
&#xD;
          -  Rash or active skin lesions overlying the scanning area (left or right flank)&#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>Barnes Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 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>
    <mesh_term>Hydronephrosis</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/NCT03774719
org study id: 201903192-1985080800
nct id: NCT03774719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study evaluates if trainees can accurately rule out dilation of the renal collecting
      system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will
      undergo a short ultrasound training program. Patients will be adults that are hospitalized
      and have acute or subacute kidney dysfunction. The investigators will assess sensitivity,
      specificity, positive and negative predictive value of HCU compared to radiology performed
      ultrasound, and calculate potential cost savings to the patient and to the healthcare system.
Hand-carried ultrasound is an increasingly popular imaging modality and is widely used by
      emergency physicians, intensivists, trauma doctors and cardiologists. Renal ultrasonography
      is commonly ordered for patients with acute kidney injury, with a main focus on identifying
      obstruction of the collecting system, a rare but potentially reversible cause of acute kidney
      injury.

      This study's aim is to evaluate if nephrology and internal medicine trainees can accurately
      rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using
      hand-carried ultrasound (HCU). Trainees will undergo a short, uniform and well described
      ultrasound training program. Patients will be adults that are hospitalized and have acute or
      subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive
      and negative predictive value of HCU compared to radiology performed ultrasound, and
      calculate potential cost savings to the patient and to the healthcare system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Absence of hydronephrosis
time frame: Through study completion, an average of 1 year
description: None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system)
measure: Direct costs of hand-carried ultrasound
time frame: 1 year
description: Direct costs in $ of hand-carried ultrasound will be calculated and compared to the costs of radiology performed ultrasound. For hand-carried ultrasound, this will include costs of purchasing the device, training costs, yearly depreciation of the hand-carried ultrasound device. For radiology performed ultrasound, this will include the sonographer's fee, radiologist fee for interpretation of the result, transportation fee by hospital transport and depreciation of the ultrasound machine.
measure: Ultrasound image quality
time frame: Through study completion, an average of 1 year
description: Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.
measure: Technical difficulty of the ultrasound study
time frame: Through study completion, an average of 1 year
description: How technically difficult was it for the trainees to obtain the images (patient intubated, obesity etc.) as graded by the trainees who performed the ultrasound scans themselves. Trainees will grade difficulty using the following measurement scale (1) Technically easy: trainee able to get clear images of both kidneys within a timeframe of 10 minutes (2) Technically challenging: Trainee able to get clear images of kidneys but requiring more than 10 minutes of scanning time (3) Technically difficult: trainee unable to get clear images of both kidneys independent of time spent scanning.
arm group label: Hand-carried ultrasound arm
arm group type: Experimental
description: This is the only arm of the study. It will be comprised of 154 inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis.
intervention type: Device
intervention name: Hand-carried ultrasound
description: Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA).
arm group label: Hand-carried ultrasound arm
other name: Point of care ultrasound
other name: POCUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Hydronephrosis
sharing ipd: No