<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/NCT04500483</url>
  </required_header>
  <id_info>
    <org_study_id>CaloIF</org_study_id>
    <nct_id>NCT04500483</nct_id>
  </id_info>
  <brief_title>Indirect Calorimetry in Patients at Risk of Malnutrition</brief_title>
  <official_title>Measurement of Resting Energy Expenditure in Burn or Critically Ill Patients at Risk of Malnutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition.&#xD;
      There are no clear guidelines determining the energy target in those two populations. The aim&#xD;
      of this observation study is to measure the resting energy expenditure of those patients,&#xD;
      using indirect calorimetry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2023</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>resting energy expenditure</measure>
    <time_frame>during the 7 days following injury in burn patients or following ICU discharge in ICU survivors</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Burns</condition>
  <condition>Critical Illness</condition>
  <condition>Indirect Calorimetry</condition>
  <condition>Resting Energy Expenditure</condition>
  <condition>Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>Burn outpatients</arm_group_label>
    <description>Burn patients treated for minor burns in an outpatient setting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICU survivors</arm_group_label>
    <description>Critically ill patients who survived ICU stay and are admitted in a general ward</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>indirect calorimetry</intervention_name>
    <description>measurement of resting energy expenditure using indirect calorimetry</description>
    <arm_group_label>Burn outpatients</arm_group_label>
    <arm_group_label>ICU survivors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the study population is divided into two groups: burn patients with minor burn exclusively&#xD;
        treated in an outpatient setting, and ICU survivors who were discharged fro ICU after a&#xD;
        stay of at least 7 days&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  minor burn treated in an outpatient setting&#xD;
&#xD;
          -  ICU survivor, who was discharged from ICU after a stay of at least 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  oxygen supply&#xD;
&#xD;
          -  chest drainage&#xD;
&#xD;
          -  not french speaking&#xD;
&#xD;
          -  confusion, coma&#xD;
&#xD;
          -  cognitive disorder&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne-Françoise Rousseau, MD, PhD</last_name>
    <phone>+3243667495</phone>
    <email>afrousseau@chuliege.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital of Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Françoise Rousseau, PhD</last_name>
      <phone>+3243667495</phone>
      <email>afrousseau@chuliege.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>June 25, 2023</last_update_submitted>
  <last_update_submitted_qc>June 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Anne-Françoise Rousseau</investigator_full_name>
    <investigator_title>Head of clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04500483
org study id: CaloIF
nct id: NCT04500483
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition.
      There are no clear guidelines determining the energy target in those two populations. The aim
      of this observation study is to measure the resting energy expenditure of those patients,
      using indirect calorimetry.
observational model: Cohort
time perspective: Prospective
measure: resting energy expenditure
time frame: during the 7 days following injury in burn patients or following ICU discharge in ICU survivors
arm group label: Burn outpatients
description: Burn patients treated for minor burns in an outpatient setting
arm group label: ICU survivors
description: Critically ill patients who survived ICU stay and are admitted in a general ward
intervention type: Diagnostic Test
intervention name: indirect calorimetry
description: measurement of resting energy expenditure using indirect calorimetry
arm group label: Burn outpatients
arm group label: ICU survivors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Françoise Rousseau, MD, PhD
phone: +3243667495
email: afrousseau@chuliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Anne-Françoise Rousseau
investigator title: Head of clinic
mesh term: Malnutrition
mesh term: Nutrition Disorders
mesh term: Critical Illness
sharing ipd: No