<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/NCT02249845</url>
  </required_header>
  <id_info>
    <org_study_id>CDS</org_study_id>
    <nct_id>NCT02249845</nct_id>
  </id_info>
  <brief_title>Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children</brief_title>
  <official_title>Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale,&#xD;
      Gorelick scale) among small children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eligible patient admitted to the hospital with acute diarrhea, after given written&#xD;
      consent for participation in the study by the child's parents, will be clinically assessed.&#xD;
      Dehydration syndromes noted by physician will be recorded in special form (in attachment).&#xD;
      Than, the child will be weighted on a standard scale.&#xD;
&#xD;
      The next body mass evaluation will take place, when patient's clinical condition will by&#xD;
      classified as good by the attending physician and the child will be at least 24 hours after&#xD;
      finishing intravenous or probe rehydration therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</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>CDS scale evaluation</measure>
    <time_frame>all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)</time_frame>
    <description>sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration &lt;3%, 3-6%, &gt;6%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WHO scale evaluation</measure>
    <time_frame>all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)</time_frame>
    <description>sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration &lt;5%, 5-10%, &gt;10%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gorelick scale evaluation</measure>
    <time_frame>when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)</time_frame>
    <description>sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration ≥5%, ≥10%</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>dehydration scales</arm_group_label>
    <description>children aged 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Small children with acute diarrhoea admitted to the pediatric ward.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick&#xD;
             scale&#xD;
&#xD;
          -  hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of&#xD;
             evacuations ≥ 3 in 24 hours; with or without fever or vomiting)&#xD;
&#xD;
          -  duration of symptoms under 5 days&#xD;
&#xD;
          -  parents' written consent for child's participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dehydration caused by other mechanisms than acute diarrhea, for example dehydration&#xD;
             caused by:&#xD;
&#xD;
               -  acidosis&#xD;
&#xD;
               -  kidney failure&#xD;
&#xD;
               -  heart failure&#xD;
&#xD;
               -  chronic liver disease&#xD;
&#xD;
               -  respiratory failure&#xD;
&#xD;
               -  condition after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Falszewska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Falszewska, MD</last_name>
    <phone>+48224523309</phone>
    <email>annafalszewska@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pediatrics, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>01-184</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Anna Falszewska, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Małgorzata Piescik, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Piotr Dziechciarz, MD</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>dehydration</keyword>
  <keyword>children</keyword>
  <keyword>gastroenteritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</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/NCT02249845
org study id: CDS
nct id: NCT02249845
lead sponsor: 
has dmc: No
The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale,
      Gorelick scale) among small children.
The eligible patient admitted to the hospital with acute diarrhea, after given written
      consent for participation in the study by the child's parents, will be clinically assessed.
      Dehydration syndromes noted by physician will be recorded in special form (in attachment).
      Than, the child will be weighted on a standard scale.

      The next body mass evaluation will take place, when patient's clinical condition will by
      classified as good by the attending physician and the child will be at least 24 hours after
      finishing intravenous or probe rehydration therapy.
observational model: Cohort
time perspective: Prospective
measure: CDS scale evaluation
time frame: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
description: sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration <3%, 3-6%, >6%
measure: WHO scale evaluation
time frame: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
description: sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration <5%, 5-10%, >10%
measure: Gorelick scale evaluation
time frame: when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
description: sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration ≥5%, ≥10%
arm group label: dehydration scales
description: children aged 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 5 Years
healthy volunteers: No
last name: Anna Falszewska, MD
role: Principal Investigator
affiliation: Medical University of Warsaw
last name: Anna Falszewska, MD
phone: +48224523309
email: annafalszewska@gmail.com
facility: 
status: Recruiting
investigator: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Piotr Dziechciarz, MD
investigator title: Medical Doctor
mesh term: Dehydration