<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/NCT04404114</url>
  </required_header>
  <id_info>
    <org_study_id>202001091RINC</org_study_id>
    <nct_id>NCT04404114</nct_id>
  </id_info>
  <brief_title>Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease</brief_title>
  <acronym>CKD-SWE</acronym>
  <official_title>Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease is a common global public health issue and its prevalence increased&#xD;
      year by year. Early diagnosis and intervention can prevent further complications and&#xD;
      comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve&#xD;
      the patients' life quality. To differentiate acute from chronic kidney disease was crucial&#xD;
      especially in the setting of crowded and high-risk emergency department. To diagnose acute or&#xD;
      chronic kidney disease, physicians usually use blood sample test combined with image studies&#xD;
      such as conventional sonography, CT and MRI. However, there was lots of limited factors. The&#xD;
      patients may have no previous visit records, poor renal function to receive contrast medium,&#xD;
      or critical clinical condition to undergo time-wasting exam. Although the conventional renal&#xD;
      sonography is accessible and inexpensive, the judgement is subjective and provide little&#xD;
      clinical information. Recent researches of shear wave elastography in evaluating renal&#xD;
      parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to&#xD;
      facilitating clinical implication, the investigators will use swear-wave elastography&#xD;
      combined with conventional renal sonography to benefit patients in diagnosis of acute or&#xD;
      chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a case-control study. The investigators obtained data from participants who were&#xD;
      older than 20 years old and received renal sonography examination in the emergency department&#xD;
      of National Taiwan University Hospital. The investigators examined the participants' kidneys&#xD;
      by recording the kidney size, cortical thickness, possible lesions and elasticity by&#xD;
      shear-wave elastography. These data combined with the participants' medical history and renal&#xD;
      function revealed by blood examination will be analyzed. This study was designed to determine&#xD;
      the correlation between renal cortical elasticity and chronic kidney disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>To determine the correlation of kPa ratio and renal function in chronic renal disease</measure>
    <time_frame>change in renal function after 2 weeks</time_frame>
    <description>The analysis will be conducted to determine the correlation between kPa ratio measured by elastography and renal function in patients with chronic renal disease</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Elastography</condition>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Normal renal function</arm_group_label>
    <description>Normal renal function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute kidney injury in normal kidney</arm_group_label>
    <description>Acute kidney injury in normal kidney</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute kidney injury in chronic kidney disease</arm_group_label>
    <description>Acute kidney injury in chronic kidney disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic kidney disease</arm_group_label>
    <description>Chronic kidney disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shear wave elastography to distinguish AKI from normal kidney</intervention_name>
    <description>Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography</description>
    <arm_group_label>Acute kidney injury in normal kidney</arm_group_label>
    <arm_group_label>Normal renal function</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shear wave elastography to distinguish AKI from CKD</intervention_name>
    <description>Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography</description>
    <arm_group_label>Acute kidney injury in chronic kidney disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shear wave elastography to distinguish CKD from normal kidney</intervention_name>
    <description>Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography</description>
    <arm_group_label>Chronic kidney disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 400 patients with normal kidney function and 400 patients with abnormal&#xD;
        kidney function&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients older than 20 years old who needed to receive renal sonography in&#xD;
             emergency department of National Taiwan University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who didn't obtain agreement.&#xD;
&#xD;
          -  The patients who can't cooperate or follow the directions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wan C. Lien, A.P</last_name>
    <phone>+886 972651315</phone>
    <email>dtemer17@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jia Yu Chen, Resident</last_name>
    <phone>+886 972652447</phone>
    <email>qwe96963@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wan-Ching Lien, MD., PhD</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>65637</phone_ext>
      <email>wanchinglien@ntu.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Jia-Yu Chen, MD.</last_name>
      <email>qwe96963@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jia-Yu Chen, MD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>An-bu Lee, MD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT04404114
org study id: 202001091RINC
nct id: NCT04404114
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chronic kidney disease is a common global public health issue and its prevalence increased
      year by year. Early diagnosis and intervention can prevent further complications and
      comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve
      the patients' life quality. To differentiate acute from chronic kidney disease was crucial
      especially in the setting of crowded and high-risk emergency department. To diagnose acute or
      chronic kidney disease, physicians usually use blood sample test combined with image studies
      such as conventional sonography, CT and MRI. However, there was lots of limited factors. The
      patients may have no previous visit records, poor renal function to receive contrast medium,
      or critical clinical condition to undergo time-wasting exam. Although the conventional renal
      sonography is accessible and inexpensive, the judgement is subjective and provide little
      clinical information. Recent researches of shear wave elastography in evaluating renal
      parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to
      facilitating clinical implication, the investigators will use swear-wave elastography
      combined with conventional renal sonography to benefit patients in diagnosis of acute or
      chronic kidney disease.
This is a case-control study. The investigators obtained data from participants who were
      older than 20 years old and received renal sonography examination in the emergency department
      of National Taiwan University Hospital. The investigators examined the participants' kidneys
      by recording the kidney size, cortical thickness, possible lesions and elasticity by
      shear-wave elastography. These data combined with the participants' medical history and renal
      function revealed by blood examination will be analyzed. This study was designed to determine
      the correlation between renal cortical elasticity and chronic kidney disease.
observational model: Case-Control
time perspective: Prospective
measure: To determine the correlation of kPa ratio and renal function in chronic renal disease
time frame: change in renal function after 2 weeks
description: The analysis will be conducted to determine the correlation between kPa ratio measured by elastography and renal function in patients with chronic renal disease
arm group label: Normal renal function
description: Normal renal function
arm group label: Acute kidney injury in normal kidney
description: Acute kidney injury in normal kidney
arm group label: Acute kidney injury in chronic kidney disease
description: Acute kidney injury in chronic kidney disease
arm group label: Chronic kidney disease
description: Chronic kidney disease
intervention type: Diagnostic Test
intervention name: Shear wave elastography to distinguish AKI from normal kidney
description: Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
arm group label: Acute kidney injury in normal kidney
arm group label: Normal renal function
intervention type: Diagnostic Test
intervention name: Shear wave elastography to distinguish AKI from CKD
description: Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
arm group label: Acute kidney injury in chronic kidney disease
intervention type: Diagnostic Test
intervention name: Shear wave elastography to distinguish CKD from normal kidney
description: Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
arm group label: Chronic kidney disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Wan C. Lien, A.P
phone: +886 972651315
email: dtemer17@yahoo.com.tw
last name: Jia Yu Chen, Resident
phone: +886 972652447
email: qwe96963@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic