<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/NCT01665664</url>
  </required_header>
  <id_info>
    <org_study_id>0014-12-WOMC</org_study_id>
    <nct_id>NCT01665664</nct_id>
  </id_info>
  <brief_title>Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients</brief_title>
  <official_title>Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Underfeeding in the critically ill patient is a common observable fact throughout intensive&#xD;
      care units. Patients who develop caloric deficit during their stay in the ICU have been shown&#xD;
      in previous reports to be associated with increased complications such as increased rate of&#xD;
      infections, and nosocomial blood stream infections. Yet, other studies have shown that&#xD;
      patients with moderate caloric deficit may be associated with better outcome than patients&#xD;
      who receive higher levels of caloric intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therefore, the aim of our study is to establish the exact amount of calories to be delivered&#xD;
      by indirect calorimetry individually for each patient. Thereafter, each patient will be&#xD;
      randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality, ICU mortality, Hospital mortality.</measure>
    <time_frame>1 year</time_frame>
    <description>All cause mortality, ICU mortality, Hospital mortality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,</measure>
    <time_frame>1 year</time_frame>
    <description>ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Enteral Feeding</condition>
  <arm_group>
    <arm_group_label>Hypocaloric feeding group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full energy feeding group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypocaloric feeding</intervention_name>
    <description>Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.</description>
    <arm_group_label>Hypocaloric feeding group</arm_group_label>
    <other_name>trophic group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anticipated Mechanical ventilation for at least 72 hrs.&#xD;
&#xD;
          -  Need for enteral feeding&#xD;
&#xD;
          -  men and woman aged 18 or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominal surgery with inability to feed enterally.&#xD;
&#xD;
          -  FiO2 greater than 80%&#xD;
&#xD;
          -  Bronchopleural fistula&#xD;
&#xD;
          -  Hemodynamic instability in spite the use of vassopressors.&#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_official>
    <last_name>Arie Soroksky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arie Soroksky, M.D.</last_name>
    <phone>972-50-4056787</phone>
    <email>soroksky@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wolfson MC</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Arie Soroksky, MD</last_name>
      <phone>972-50-4056787</phone>
      <email>soroksky@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Arie Soroksky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Soroksky Arie</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Indirect calorimetry</keyword>
  <keyword>hypocaloric feeding</keyword>
  <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/NCT01665664
org study id: 0014-12-WOMC
nct id: NCT01665664
lead sponsor: 
has dmc: No
Underfeeding in the critically ill patient is a common observable fact throughout intensive
      care units. Patients who develop caloric deficit during their stay in the ICU have been shown
      in previous reports to be associated with increased complications such as increased rate of
      infections, and nosocomial blood stream infections. Yet, other studies have shown that
      patients with moderate caloric deficit may be associated with better outcome than patients
      who receive higher levels of caloric intake.
Therefore, the aim of our study is to establish the exact amount of calories to be delivered
      by indirect calorimetry individually for each patient. Thereafter, each patient will be
      randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: All cause mortality, ICU mortality, Hospital mortality.
time frame: 1 year
description: All cause mortality, ICU mortality, Hospital mortality.
measure: ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
time frame: 1 year
description: ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,
arm group label: Hypocaloric feeding group
arm group type: Other
description: intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
arm group label: Full energy feeding group
arm group type: No Intervention
description: Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided.
intervention type: Other
intervention name: Hypocaloric feeding
description: Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
arm group label: Hypocaloric feeding group
other name: trophic group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arie Soroksky, MD
role: Principal Investigator
affiliation: Wolfson MC
last name: Arie Soroksky, M.D.
phone: 972-50-4056787
email: soroksky@gmail.com
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Soroksky Arie
investigator title: M.D.
mesh term: Critical Illness