<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/NCT03021109</url>
  </required_header>
  <id_info>
    <org_study_id>2016/278</org_study_id>
    <nct_id>NCT03021109</nct_id>
  </id_info>
  <brief_title>Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis</brief_title>
  <official_title>Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derince Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derince Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is assessment of volume status by bedside ultrasound in children&#xD;
      with acute gastroenteritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will be conducted of emergency medicine department in the Derince Training and&#xD;
      Research Hospital. Patients referred to acute gastroenteritis will be included to the study.&#xD;
      After initial evaluation, the clinician will inform the principal investigator about the&#xD;
      patient. The principal investigator will record the patient's demographic data, contact&#xD;
      information, vital signs, history, physical examination findings, and weight. Than expirium&#xD;
      and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound&#xD;
      and caval index will be calculated. An investigator who have had an ultrasound certification&#xD;
      by Emergency Medicine Association of Turkey for six years will make the measurements. After 1&#xD;
      week the patient will called up for re-evaluation. Applicants' weights will be measured again&#xD;
      with the same weighing machine. The differences between initial and after one week weight&#xD;
      measurement will be accepted as the gold standard method for volume loss. The weight loss of&#xD;
      the patient, the dehydration findings detected on physical examination and the caval index&#xD;
      will be compared.&#xD;
&#xD;
      Data will be collected on predesigned data sheets, by an investigator and subsequently will&#xD;
      be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be&#xD;
      checked by an another investigator to identify possible errors. Results will be submitted at&#xD;
      least every two months.&#xD;
&#xD;
      Linear regression will be performed with dehydration as the dependent variable and the caval&#xD;
      index as the independent variable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</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>The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Dehydration</condition>
  <condition>Acute Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Inferior vena cava diameteres</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measurement of inferior vena cava diameters with ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Measurement of inferior vena cava diameters with ultrasound</intervention_name>
    <description>The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium</description>
    <arm_group_label>Inferior vena cava diameteres</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 6 months and 18 years of age who presented to the Emergency&#xD;
             Department with gastroenteritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  chronic liver disease&#xD;
&#xD;
          -  chronic renal disease&#xD;
&#xD;
          -  patients or parents who doesn't want to enroll the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asım E. Özbek, Specialist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli Derince Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli Derince Training and Research Hospital</name>
      <address>
        <city>Kocaeli</city>
        <state>Izmit</state>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.who.int/mediacentre/factsheets/fs330/en/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>van den Berg J, Berger MY. Guidelines on acute gastroenteritis in children: a critical appraisal of their quality and applicability in primary care. BMC Fam Pract. 2011 Dec 2;12:134. doi: 10.1186/1471-2296-12-134.</citation>
    <PMID>22136388</PMID>
  </reference>
  <reference>
    <citation>Liebelt EL. Clinical and laboratory evaluation and management of children with vomiting, diarrhea, and dehydration. Curr Opin Pediatr. 1998 Oct;10(5):461-9. doi: 10.1097/00008480-199810000-00002.</citation>
    <PMID>9818241</PMID>
  </reference>
  <reference>
    <citation>Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.</citation>
    <PMID>15187057</PMID>
  </reference>
  <reference>
    <citation>McConnochie KM, Conners GP, Lu E, Wilson C. How commonly are children hospitalized for dehydration eligible for care in alternative settings? Arch Pediatr Adolesc Med. 1999 Dec;153(12):1233-41. doi: 10.1001/archpedi.153.12.1233.</citation>
    <PMID>10591299</PMID>
  </reference>
  <reference>
    <citation>Haciomeroglu P, Ozkaya O, Gunal N, Baysal K. Venous collapsibility index changes in children on dialysis. Nephrology (Carlton). 2007 Apr;12(2):135-9. doi: 10.1111/j.1440-1797.2006.00700.x.</citation>
    <PMID>17371335</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>October 14, 2017</last_update_submitted>
  <last_update_submitted_qc>October 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derince Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ASIM ENES ÖZBEK</investigator_full_name>
    <investigator_title>Emergency medicine specialist</investigator_title>
  </responsible_party>
  <keyword>ultrasound</keyword>
  <keyword>pediatrics</keyword>
  <keyword>gastroenteritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Dehydration</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/NCT03021109
org study id: 2016/278
nct id: NCT03021109
lead sponsor: 
has dmc: Yes
The purpose of the study is assessment of volume status by bedside ultrasound in children
      with acute gastroenteritis
The research will be conducted of emergency medicine department in the Derince Training and
      Research Hospital. Patients referred to acute gastroenteritis will be included to the study.
      After initial evaluation, the clinician will inform the principal investigator about the
      patient. The principal investigator will record the patient's demographic data, contact
      information, vital signs, history, physical examination findings, and weight. Than expirium
      and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound
      and caval index will be calculated. An investigator who have had an ultrasound certification
      by Emergency Medicine Association of Turkey for six years will make the measurements. After 1
      week the patient will called up for re-evaluation. Applicants' weights will be measured again
      with the same weighing machine. The differences between initial and after one week weight
      measurement will be accepted as the gold standard method for volume loss. The weight loss of
      the patient, the dehydration findings detected on physical examination and the caval index
      will be compared.

      Data will be collected on predesigned data sheets, by an investigator and subsequently will
      be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be
      checked by an another investigator to identify possible errors. Results will be submitted at
      least every two months.

      Linear regression will be performed with dehydration as the dependent variable and the caval
      index as the independent variable.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
time frame: 1 week
measure: The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
time frame: 1 week
arm group label: Inferior vena cava diameteres
arm group type: Experimental
description: Measurement of inferior vena cava diameters with ultrasound
intervention type: Device
intervention name: Measurement of inferior vena cava diameters with ultrasound
description: The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium
arm group label: Inferior vena cava diameteres
criteria: 
gender: All
minimum age: 6 Months
maximum age: 17 Years
healthy volunteers: No
last name: Asım E. Özbek, Specialist
role: Principal Investigator
affiliation: Kocaeli Derince Training and Research Hospital
facility: 
country: Turkey
url: http://www.who.int/mediacentre/factsheets/fs330/en/
description: Related Info
citation: van den Berg J, Berger MY. Guidelines on acute gastroenteritis in children: a critical appraisal of their quality and applicability in primary care. BMC Fam Pract. 2011 Dec 2;12:134. doi: 10.1186/1471-2296-12-134.
PMID: 22136388
citation: Liebelt EL. Clinical and laboratory evaluation and management of children with vomiting, diarrhea, and dehydration. Curr Opin Pediatr. 1998 Oct;10(5):461-9. doi: 10.1097/00008480-199810000-00002.
PMID: 9818241
citation: Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.
PMID: 15187057
citation: McConnochie KM, Conners GP, Lu E, Wilson C. How commonly are children hospitalized for dehydration eligible for care in alternative settings? Arch Pediatr Adolesc Med. 1999 Dec;153(12):1233-41. doi: 10.1001/archpedi.153.12.1233.
PMID: 10591299
citation: Haciomeroglu P, Ozkaya O, Gunal N, Baysal K. Venous collapsibility index changes in children on dialysis. Nephrology (Carlton). 2007 Apr;12(2):135-9. doi: 10.1111/j.1440-1797.2006.00700.x.
PMID: 17371335
responsible party type: Principal Investigator
investigator affiliation: Derince Training and Research Hospital
investigator full name: ASIM ENES ÖZBEK
investigator title: Emergency medicine specialist
mesh term: Gastroenteritis
mesh term: Dehydration
sharing ipd: Undecided