<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/NCT04463082</url>
  </required_header>
  <id_info>
    <org_study_id>FNO-OPRIP-US-fluids</org_study_id>
    <nct_id>NCT04463082</nct_id>
  </id_info>
  <brief_title>Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound</brief_title>
  <official_title>Assessment of the Current State of Volume Status in Children by Ultrasound Measurement of Vena Cava Inferior and Vena Jugularis Interna Combined With Passive Leg Raise: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ostrava</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Ostrava</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with clinical signs of severe dehydration will be examined by ultrasound in a supine&#xD;
      position during admission. Children aged between 1 and 15years will be divided into three&#xD;
      weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters&#xD;
      of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae&#xD;
      jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver&#xD;
      will be recorded. After a defined fluid infusion within 60 minutes, a second examination will&#xD;
      be evaluated and compared with the first one. The investigators considered also&#xD;
      echocardiography to measure CO changes however they wanted to make it as simple as it might&#xD;
      be at emergency during the night shift without an experienced cardiologist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only children admitted to the hospital with clinically detectable dehydration (weight loss,&#xD;
      dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure&#xD;
      measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound&#xD;
      probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine&#xD;
      position, the ultrasound probe will be placed in the substernal area, in the longitudinal and&#xD;
      transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be&#xD;
      operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and&#xD;
      the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI&#xD;
      max x100). Immediately after this examination measurement of the right VJImax, min and the&#xD;
      left VJImax, min will be measured again in the supine position, then after passive leg raise&#xD;
      (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will&#xD;
      be measured. The collapsibility index for right and left VJI would be calculated according to&#xD;
      the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but&#xD;
      the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply&#xD;
      not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI&#xD;
      will be evaluated the same way as first and compared with the previous one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in vena cava inferior diameter pre- and post-hydration</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in vena jugularis interna diameter pre- and post-hydration (on the right side)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in vena jugularis interna diameter pre- and post-hydration (on the left side)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in collapsibility index pre- and post-hydration</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in collapsibility index values (in per cent) will be measured before and after hydration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation to body surface area</measure>
    <time_frame>60 minutes</time_frame>
    <description>All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gastroenteritis</condition>
  <condition>Diabetes Mellitus (Ketoacidosis)</condition>
  <arm_group>
    <arm_group_label>Weight category 10-20kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric patients with a weight of 10-20kg will be enrolled in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight category 20-30kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric patients with a weight of 20-30kg will be enrolled in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight category 30-50kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric patients with a weight of 30-50kg will be enrolled in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intravenous administration of fluids</intervention_name>
    <description>Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.</description>
    <arm_group_label>Weight category 10-20kg</arm_group_label>
    <arm_group_label>Weight category 20-30kg</arm_group_label>
    <arm_group_label>Weight category 30-50kg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  previously healthy children&#xD;
&#xD;
          -  history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital heart diseases&#xD;
&#xD;
          -  intestinal obstruction&#xD;
&#xD;
          -  any signs of abdominal hypertension&#xD;
&#xD;
          -  any illnesses known to affect the volume status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomáš Zaoral, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Moravian-Silesian Region</state>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Unluer EE, Kara PH. Ultrasonography of jugular vein as a marker of hypovolemia in healthy volunteers. Am J Emerg Med. 2013 Jan;31(1):173-7. doi: 10.1016/j.ajem.2012.07.003. Epub 2012 Sep 11.</citation>
    <PMID>22980368</PMID>
  </reference>
  <reference>
    <citation>Bauman Z, Coba V, Gassner M, Amponsah D, Gallien J, Blyden D, Killu K. Inferior vena cava collapsibility loses correlation with internal jugular vein collapsibility during increased thoracic or intra-abdominal pressure. J Ultrasound. 2015 Sep 18;18(4):343-8. doi: 10.1007/s40477-015-0181-2. eCollection 2015 Dec.</citation>
    <PMID>26550073</PMID>
  </reference>
  <reference>
    <citation>Lu GP, Yan G, Chen Y, Lu ZJ, Zhang LE, Kissoon N. The passive leg raise test to predict fluid responsiveness in children--preliminary observations. Indian J Pediatr. 2015 Jan;82(1):5-12. doi: 10.1007/s12098-013-1303-5. Epub 2013 Dec 11.</citation>
    <PMID>24327086</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>dehydration</keyword>
  <keyword>ultrasound</keyword>
  <keyword>vena cava inferior</keyword>
  <keyword>vena jugularis</keyword>
  <keyword>passive leg raise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Ketosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.</ipd_description>
  </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/NCT04463082
org study id: FNO-OPRIP-US-fluids
nct id: NCT04463082
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with clinical signs of severe dehydration will be examined by ultrasound in a supine
      position during admission. Children aged between 1 and 15years will be divided into three
      weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters
      of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae
      jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver
      will be recorded. After a defined fluid infusion within 60 minutes, a second examination will
      be evaluated and compared with the first one. The investigators considered also
      echocardiography to measure CO changes however they wanted to make it as simple as it might
      be at emergency during the night shift without an experienced cardiologist.
Only children admitted to the hospital with clinically detectable dehydration (weight loss,
      dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure
      measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound
      probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine
      position, the ultrasound probe will be placed in the substernal area, in the longitudinal and
      transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be
      operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and
      the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI
      max x100). Immediately after this examination measurement of the right VJImax, min and the
      left VJImax, min will be measured again in the supine position, then after passive leg raise
      (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will
      be measured. The collapsibility index for right and left VJI would be calculated according to
      the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but
      the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply
      not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI
      will be evaluated the same way as first and compared with the previous one.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in vena cava inferior diameter pre- and post-hydration
time frame: 60 minutes
description: Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.
measure: Change in vena jugularis interna diameter pre- and post-hydration (on the right side)
time frame: 60 minutes
description: Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).
measure: Change in vena jugularis interna diameter pre- and post-hydration (on the left side)
time frame: 60 minutes
description: Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).
measure: Change in collapsibility index pre- and post-hydration
time frame: 60 minutes
description: Change in collapsibility index values (in per cent) will be measured before and after hydration.
measure: Correlation to body surface area
time frame: 60 minutes
description: All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)
arm group label: Weight category 10-20kg
arm group type: Experimental
description: Pediatric patients with a weight of 10-20kg will be enrolled in this arm.
arm group label: Weight category 20-30kg
arm group type: Experimental
description: Pediatric patients with a weight of 20-30kg will be enrolled in this arm.
arm group label: Weight category 30-50kg
arm group type: Experimental
description: Pediatric patients with a weight of 30-50kg will be enrolled in this arm.
intervention type: Procedure
intervention name: Intravenous administration of fluids
description: Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
arm group label: Weight category 10-20kg
arm group label: Weight category 20-30kg
arm group label: Weight category 30-50kg
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
last name: Tomáš Zaoral, MD,PhD
role: Principal Investigator
affiliation: University Hospital Ostrava
facility: 
country: Czechia
citation: Unluer EE, Kara PH. Ultrasonography of jugular vein as a marker of hypovolemia in healthy volunteers. Am J Emerg Med. 2013 Jan;31(1):173-7. doi: 10.1016/j.ajem.2012.07.003. Epub 2012 Sep 11.
PMID: 22980368
citation: Bauman Z, Coba V, Gassner M, Amponsah D, Gallien J, Blyden D, Killu K. Inferior vena cava collapsibility loses correlation with internal jugular vein collapsibility during increased thoracic or intra-abdominal pressure. J Ultrasound. 2015 Sep 18;18(4):343-8. doi: 10.1007/s40477-015-0181-2. eCollection 2015 Dec.
PMID: 26550073
citation: Lu GP, Yan G, Chen Y, Lu ZJ, Zhang LE, Kissoon N. The passive leg raise test to predict fluid responsiveness in children--preliminary observations. Indian J Pediatr. 2015 Jan;82(1):5-12. doi: 10.1007/s12098-013-1303-5. Epub 2013 Dec 11.
PMID: 24327086
responsible party type: Sponsor
mesh term: Gastroenteritis
mesh term: Ketosis
sharing ipd: No
ipd description: The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.