<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/NCT01696175</url>
  </required_header>
  <id_info>
    <org_study_id>PALVOS</org_study_id>
    <nct_id>NCT01696175</nct_id>
  </id_info>
  <brief_title>PICU Admission Lactate and Central Venous Oxymetry Study</brief_title>
  <acronym>PALVOS</acronym>
  <official_title>Lactate Levels and Venous Oxygen Saturation in Children Admitted to a Dutch PICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Dutch Network of Excellence for Pediatric Intensive Care Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for&#xD;
      lactate levels and ScvO2. Children instrumented with arterial and central venous catheters&#xD;
      are included within the first 12 hours after admittance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Hemodynamic therapy in children with circulatory insufficiency requires the use of&#xD;
      hemodynamic monitoring parameters including parameters that reflect tissue/organ oxygenation&#xD;
      and oxygen utilization. Two parameters are readily available at the bedside that may reflect&#xD;
      this: arterial lactate level and central venous oxygen saturation (ScvO2). To date is it&#xD;
      unknown if these parameters are useful in guiding treatment of critically ill children. Also&#xD;
      it is unknown how often lactate and ScvO2 are abnormal in children admitted to a Dutch PICU&#xD;
      or if they are related to each.&#xD;
&#xD;
      Objective: The objective of this study is to find the incidence of a raised lactate level and&#xD;
      or a decreased ScvO2, to study their mutual relation and to study the relation between&#xD;
      lactate, ScvO2 and outcome parameters in children admitted to a Dutch PICU.&#xD;
&#xD;
      Study design: Observational cohort study&#xD;
&#xD;
      Study population: children admitted to a PICU &lt;= 16 years&#xD;
&#xD;
      Intervention (if applicable): No intervention&#xD;
&#xD;
      Main study parameters/endpoints: Arterial lactate level, central venous oxygen saturation&#xD;
      (ScvO2), arterial blood gas analysis and general hemodynamic variables in the first 24 hours&#xD;
      after admission. Parameters for organ dysfunction, severity of illness and outcome parameters&#xD;
      like length of PICU stay.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: This is a strict observational design. No blood samples are taken for the&#xD;
      purpose of this study. No intravascular catheters are inserted for the purpose of this study.&#xD;
      No treatment strategy is associated with this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Researcher stopped activity at institution&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU</measure>
    <time_frame>first 24 hours after admission</time_frame>
    <description>What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Shock</condition>
  <arm_group>
    <arm_group_label>PICU admittance</arm_group_label>
    <description>Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Al children admitted to a PICU &lt;= 16 years equipped with an arterial and central venous&#xD;
        catheter in situ at admission or inserted within &lt; 12 hours after admission to the PICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Al children admitted to a PICU &lt;= 16 years equipped with an arterial and central&#xD;
             venous catheter in situ at admission or inserted within &lt; 12 hours after admission to&#xD;
             the PICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without an arterial or central venous catheter &gt; 12 hours after of admission&#xD;
&#xD;
          -  Patients with a known underlying metabolic disorder causing an elevated lactate level&#xD;
&#xD;
          -  Patients with asthma and therapy (nebulized or intravenous) with salbutamol.&#xD;
&#xD;
          -  Patients with an intoxication causing elevated lactate levels&#xD;
&#xD;
          -  Premature children (&lt;38 weeks GA)&#xD;
&#xD;
          -  Patients on ECMO&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>RUNMC</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Radboud University Medical Center</investigator_affiliation>
    <investigator_full_name>Joris Lemson</investigator_full_name>
    <investigator_title>Medical director pediatric intensive care unit</investigator_title>
  </responsible_party>
  <keyword>ScvO2</keyword>
  <keyword>venous</keyword>
  <keyword>oxymetry</keyword>
  <keyword>lactate</keyword>
  <keyword>children</keyword>
  <keyword>PICU</keyword>
  <keyword>Admission parameters of shock</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</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/NCT01696175
org study id: PALVOS
nct id: NCT01696175
lead sponsor: 
collaborator: 
has dmc: No
Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for
      lactate levels and ScvO2. Children instrumented with arterial and central venous catheters
      are included within the first 12 hours after admittance.
Rationale: Hemodynamic therapy in children with circulatory insufficiency requires the use of
      hemodynamic monitoring parameters including parameters that reflect tissue/organ oxygenation
      and oxygen utilization. Two parameters are readily available at the bedside that may reflect
      this: arterial lactate level and central venous oxygen saturation (ScvO2). To date is it
      unknown if these parameters are useful in guiding treatment of critically ill children. Also
      it is unknown how often lactate and ScvO2 are abnormal in children admitted to a Dutch PICU
      or if they are related to each.

      Objective: The objective of this study is to find the incidence of a raised lactate level and
      or a decreased ScvO2, to study their mutual relation and to study the relation between
      lactate, ScvO2 and outcome parameters in children admitted to a Dutch PICU.

      Study design: Observational cohort study

      Study population: children admitted to a PICU <= 16 years

      Intervention (if applicable): No intervention

      Main study parameters/endpoints: Arterial lactate level, central venous oxygen saturation
      (ScvO2), arterial blood gas analysis and general hemodynamic variables in the first 24 hours
      after admission. Parameters for organ dysfunction, severity of illness and outcome parameters
      like length of PICU stay.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: This is a strict observational design. No blood samples are taken for the
      purpose of this study. No intravascular catheters are inserted for the purpose of this study.
      No treatment strategy is associated with this study.
observational model: Cohort
time perspective: Prospective
measure: What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU
time frame: first 24 hours after admission
description: What is the incidence of a decreased ScvO2 and or a raised lactate level in children admitted to Dutch PICU's in the first 24 hours after admission to the PICU
arm group label: PICU admittance
description: Children equipped with an arterial and a central venous catheter within 12 hours after admittance to a Dutch PICU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Week
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Radboud University Medical Center
investigator full name: Joris Lemson
investigator title: Medical director pediatric intensive care unit
mesh term: Shock