<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/NCT02203123</url>
  </required_header>
  <id_info>
    <org_study_id>ultrasound_01</org_study_id>
    <nct_id>NCT02203123</nct_id>
  </id_info>
  <brief_title>Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      -  There is no definite tool for measurement of dehydration in children&#xD;
&#xD;
        -  Subjective clinical dehydration scale is considered as valuable scoring system, but it&#xD;
           cannot be reliable among clinicians sometimes.&#xD;
&#xD;
        -  Some authors found Inferior vena cava/Aorta ratio can be a objective marker for&#xD;
           dehydration&#xD;
&#xD;
        -  However, there is no evidence of correlation between clinical dehydration scale and&#xD;
           inferior vena cava/aorta ratio&#xD;
&#xD;
        -  We will observe correlation between clinical dehydration scale and inferior vena&#xD;
           cava/aorta ratio and change of the ratio according to hydration with intravenous normal&#xD;
           saline infusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">April 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>diameter of inferior vena cava and aorta</measure>
    <time_frame>up to 2 hours</time_frame>
    <description>we will measure the diameter of inferior vena cava and aorta using ultrasound during every 10 ml/kg infusion of intravenous normal saline</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">226</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>Ultrasound, inferior vena cava, aorta, normal saline</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Ultrasound, inferior vena cava, aorta, normal saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <arm_group_label>Ultrasound, inferior vena cava, aorta, normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children with dehydration who visit emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  bronchopulmonary dysplasia&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Hee Lee, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Hee Lee, Professor</last_name>
    <phone>+82-31-787-7575</phone>
    <email>gienee@snubh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gumi-dong, Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Hee Lee, Professor</last_name>
      <phone>+82-31-787-7575</phone>
      <email>gienee@snubh.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin Hee Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 6, 2018</submitted>
    <returned>September 14, 2018</returned>
  </pending_results>
  <!-- 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/NCT02203123
org study id: ultrasound_01
nct id: NCT02203123
lead sponsor: 
-  There is no definite tool for measurement of dehydration in children

        -  Subjective clinical dehydration scale is considered as valuable scoring system, but it
           cannot be reliable among clinicians sometimes.

        -  Some authors found Inferior vena cava/Aorta ratio can be a objective marker for
           dehydration

        -  However, there is no evidence of correlation between clinical dehydration scale and
           inferior vena cava/aorta ratio

        -  We will observe correlation between clinical dehydration scale and inferior vena
           cava/aorta ratio and change of the ratio according to hydration with intravenous normal
           saline infusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: diameter of inferior vena cava and aorta
time frame: up to 2 hours
description: we will measure the diameter of inferior vena cava and aorta using ultrasound during every 10 ml/kg infusion of intravenous normal saline
arm group label: Ultrasound, inferior vena cava, aorta, normal saline
arm group type: Other
intervention type: Device
intervention name: Ultrasound
arm group label: Ultrasound, inferior vena cava, aorta, normal saline
intervention type: Drug
intervention name: normal saline
arm group label: Ultrasound, inferior vena cava, aorta, normal saline
criteria: 
gender: All
minimum age: 3 Months
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jin Hee Lee, Professor
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Jin Hee Lee, Professor
phone: +82-31-787-7575
email: gienee@snubh.org
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin Hee Lee
investigator title: Assistant professor
mesh term: Dehydration
submitted: January 6, 2018
returned: September 14, 2018