<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/NCT03793244</url>
  </required_header>
  <id_info>
    <org_study_id>MC_001 V1 240217</org_study_id>
    <nct_id>NCT03793244</nct_id>
  </id_info>
  <brief_title>TARGET-Metabolic Effects</brief_title>
  <acronym>TARGET-ME</acronym>
  <official_title>The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Canberra Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Adelaide Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Auckland City Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Melbourne Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</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>
      The estimation of calorie needs during routine practice in critically ill patients is highly&#xD;
      variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on&#xD;
      overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a&#xD;
      substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity&#xD;
      to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon&#xD;
      dioxide production (VCO2) to compare measured calorie utilisation to estimation methods,&#xD;
      determine the potential thermic effect of EN solutions with different energy concentrations&#xD;
      and investigate any associations with outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Calorie difference in kcal</measure>
    <time_frame>Up to day 28</time_frame>
    <description>Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calorie difference in kcal in the whole study cohort</measure>
    <time_frame>Up to day 28</time_frame>
    <description>Calorie difference in kcal between mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in the whole study cohort</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Calorie difference in kcal</measure>
    <time_frame>Up to day 28</time_frame>
    <description>Calorie difference in kcal between mean measured calorie utilisation and mean calorie requirements predicted by the estimation method used in TARGET and in routine clinical practice</description>
  </other_outcome>
  <other_outcome>
    <measure>Energy balance</measure>
    <time_frame>Up to day 28</time_frame>
    <description>Energy balance in both the intervention and standard care groups (with measured calorie utilisation as the reference) up until 4 weeks post randomisation</description>
  </other_outcome>
  <other_outcome>
    <measure>Degree of diet induced thermogenesis</measure>
    <time_frame>Up to day 28</time_frame>
    <description>measured as the difference between mean measured calorie utilisation in kcal between the two intervention groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE</measure>
    <time_frame>Up to day 28</time_frame>
    <description>Correlation (bias, precision, accuracy rates) of EE assessed by IC and VCO2 compared to predictive equations estimates of EE</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Critical Illness</condition>
  <condition>Enteral Nutrition</condition>
  <arm_group>
    <arm_group_label>Experimental: TARGET protocol EN 1.5 kcal/mL</arm_group_label>
    <description>Enteral (EN) feed 1.5 kcal/mL. Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: TARGET protocol EN 1.0 kcal/mL</arm_group_label>
    <description>Enteral feed 1.0 kcal/mL Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>TARGET protocol EN 1.5 kcal/mL</intervention_name>
    <description>Enteral nutrition</description>
    <arm_group_label>Experimental: TARGET protocol EN 1.5 kcal/mL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients who are mechanically ventilated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must first meet the inclusion and none of the exclusion criteria for the TARGET&#xD;
        main trail (NCT02306746). The following additional criteria applies for this study when&#xD;
        indirect calorimetry is being used:&#xD;
&#xD;
          -  Within 48 hours of randomisation to TARGET (first measurement only)&#xD;
&#xD;
          -  Fi02 &lt; 50% for the past 1 hour&#xD;
&#xD;
          -  Positive end expiratory pressure (PEEP) &lt; 12 mmHg for the past 1 hour&#xD;
&#xD;
          -  The IC test can be conducted within 48 hours of randomisation to TARGET&#xD;
&#xD;
          -  The patient is not considered agitated using the usual site assessment&#xD;
&#xD;
          -  There is a clinician available to complete the test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There is an air leak in the ventilation circuit (ie bubbling inter-costal catheters,&#xD;
             cuff leak at the endotracheal tube&#xD;
&#xD;
          -  The patient is receiving renal replacement therapy or extracorporeal membrane&#xD;
             oxygenation at the time of measurement&#xD;
&#xD;
          -  Has had surgery in the last 6 hours (if enough time within the 48 hour window,&#xD;
             consider waiting until this criteria is less than 6 hours)&#xD;
&#xD;
          -  If the patient has a traumatic brain injury, for the previous 6 hours, their&#xD;
             intracranial pressures have been unstable and in the opinion of the treating&#xD;
             intensivist are not controlled&#xD;
&#xD;
          -  The treating clinician believes that the IC test will pose risk to the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ANZIC-RC</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>April 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Australian and New Zealand Intensive Care Research Centre</investigator_affiliation>
    <investigator_full_name>anzicrc</investigator_full_name>
    <investigator_title>ICU Nutrition Research Program Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03793244
org study id: MC_001 V1 240217
nct id: NCT03793244
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The estimation of calorie needs during routine practice in critically ill patients is highly
      variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on
      overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a
      substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity
      to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon
      dioxide production (VCO2) to compare measured calorie utilisation to estimation methods,
      determine the potential thermic effect of EN solutions with different energy concentrations
      and investigate any associations with outcome.
observational model: Case-Only
time perspective: Prospective
measure: Calorie difference in kcal
time frame: Up to day 28
description: Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group
measure: Calorie difference in kcal in the whole study cohort
time frame: Up to day 28
description: Calorie difference in kcal between mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in the whole study cohort
measure: Calorie difference in kcal
time frame: Up to day 28
description: Calorie difference in kcal between mean measured calorie utilisation and mean calorie requirements predicted by the estimation method used in TARGET and in routine clinical practice
measure: Energy balance
time frame: Up to day 28
description: Energy balance in both the intervention and standard care groups (with measured calorie utilisation as the reference) up until 4 weeks post randomisation
measure: Degree of diet induced thermogenesis
time frame: Up to day 28
description: measured as the difference between mean measured calorie utilisation in kcal between the two intervention groups
measure: Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE
time frame: Up to day 28
description: Correlation (bias, precision, accuracy rates) of EE assessed by IC and VCO2 compared to predictive equations estimates of EE
arm group label: Experimental: TARGET protocol EN 1.5 kcal/mL
description: Enteral (EN) feed 1.5 kcal/mL. Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study
arm group label: Active Comparator: TARGET protocol EN 1.0 kcal/mL
description: Enteral feed 1.0 kcal/mL Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study
intervention type: Dietary Supplement
intervention name: TARGET protocol EN 1.5 kcal/mL
description: Enteral nutrition
arm group label: Experimental: TARGET protocol EN 1.5 kcal/mL
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Australian and New Zealand Intensive Care Research Centre
investigator full name: anzicrc
investigator title: ICU Nutrition Research Program Manager
mesh term: Critical Illness
sharing ipd: No