<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/NCT03249051</url>
  </required_header>
  <id_info>
    <org_study_id>Indirect Calorimetry in ICU</org_study_id>
    <nct_id>NCT03249051</nct_id>
  </id_info>
  <brief_title>Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.</brief_title>
  <acronym>ONCA</acronym>
  <official_title>Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hohenheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hohenheim</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 aim of this study is to investigate whether an individualized determination of energy&#xD;
      requirements using indirect calorimetry instead of a formula-based approach leads to an&#xD;
      optimized nutritional support and as a consequence to an optimized nutritional status of the&#xD;
      critically ill, mechanically ventilated patients measured by the phase angle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2016</start_date>
  <completion_date type="Actual">August 15, 2017</completion_date>
  <primary_completion_date type="Actual">August 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase angle (PhA)</measure>
    <time_frame>PhA was measured between one and 90 days (during ICU stay)</time_frame>
    <description>The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nitrogen Balance</measure>
    <time_frame>Nitrogen Balance was measured between one and 90 days (during ICU stay)</time_frame>
    <description>Difference between intervention and control group between hospital admission and discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular to body cell mass ratio (ECM/BCM - Ratio)</measure>
    <time_frame>ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)</time_frame>
    <description>Difference between intervention and control group between hospital admission and discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay in days</measure>
    <time_frame>Length of hospital stay was measured between one and 180 days</time_frame>
    <description>Difference between intervention and control group between hospital admission and discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in intensive care unit (ICU) in days</measure>
    <time_frame>Length of ICU stay was measured between one and 90 days</time_frame>
    <description>Difference between intervention and control group between hospital admission and discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>Indirect Calorimetry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group receives nutrition supply according to the hospital routine (&quot;standard care&quot;)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indirect Calorimetry</intervention_name>
    <description>Energy need is being determined using indirect Calorimetry</description>
    <arm_group_label>Indirect Calorimetry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  mechanical ventilation&#xD;
&#xD;
          -  an hospital stay of at least three days at the intensive care unit of the University&#xD;
             Hospital of Tübingen&#xD;
&#xD;
          -  possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)&#xD;
&#xD;
          -  possibility to perform Bioelectrical Impedance Analysis (BIA)&#xD;
&#xD;
          -  underlying indication for enteral or/and parenteral nutritional support&#xD;
&#xD;
          -  written informed consent from the patient or a legal authorized person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Stephan C Bischoff</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hohenheim, 70599 Stuttgart, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Hohenheim</name>
      <address>
        <city>Stuttgart</city>
        <zip>70599</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03249051
org study id: Indirect Calorimetry in ICU
nct id: NCT03249051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether an individualized determination of energy
      requirements using indirect calorimetry instead of a formula-based approach leads to an
      optimized nutritional support and as a consequence to an optimized nutritional status of the
      critically ill, mechanically ventilated patients measured by the phase angle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase angle (PhA)
time frame: PhA was measured between one and 90 days (during ICU stay)
description: The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.
measure: Nitrogen Balance
time frame: Nitrogen Balance was measured between one and 90 days (during ICU stay)
description: Difference between intervention and control group between hospital admission and discharge.
measure: Extracellular to body cell mass ratio (ECM/BCM - Ratio)
time frame: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
description: Difference between intervention and control group between hospital admission and discharge.
measure: Length of hospital stay in days
time frame: Length of hospital stay was measured between one and 180 days
description: Difference between intervention and control group between hospital admission and discharge.
measure: Length of stay in intensive care unit (ICU) in days
time frame: Length of ICU stay was measured between one and 90 days
description: Difference between intervention and control group between hospital admission and discharge.
arm group label: Indirect Calorimetry
arm group type: Experimental
description: The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
arm group label: Standard Care
arm group type: No Intervention
description: This group receives nutrition supply according to the hospital routine ("standard care")
intervention type: Other
intervention name: Indirect Calorimetry
description: Energy need is being determined using indirect Calorimetry
arm group label: Indirect Calorimetry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Stephan C Bischoff
role: Principal Investigator
affiliation: University of Hohenheim, 70599 Stuttgart, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Critical Illness