<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/NCT02208700</url>
  </required_header>
  <id_info>
    <org_study_id>1141459</org_study_id>
    <nct_id>NCT02208700</nct_id>
  </id_info>
  <brief_title>Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study</brief_title>
  <acronym>ANUS1305</acronym>
  <official_title>Efficacy of the Use of Enteral Feeding High in EPA,GLA and Antioxidants in LTAC Patients on Chronic Ventilation- a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grace Hospital, Cleveland, Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grace Hospital, Cleveland, Ohio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with mechanical ventilation have shown improved weaning rates when enteral tube&#xD;
      feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.&#xD;
&#xD;
      LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical&#xD;
      ventilation, decreased mortality rates and decreased organ failure when fed an enteral&#xD;
      product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral&#xD;
      nutrition product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Anticipated">October 2015</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>Length of days on mechanical ventilation</measure>
    <time_frame>14 days from start of enteral feeding</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Acute Lung Injury</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Oxepa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Other: Therapeutic nutrition with EPA, GLA and antioxidants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jevity 1.5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oxepa</intervention_name>
    <description>Therapeutic nutrition with EPA, GLA&lt; and antioxidants</description>
    <arm_group_label>Oxepa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Jevity 1.5</intervention_name>
    <description>Complete balanced nutrition with a unique fiber blend</description>
    <arm_group_label>Jevity 1.5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &gt;18 years old with Respiratory failure on mechanical ventilation with failure to wean&#xD;
        Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History Of pulmonary fibrosis, Terminal illness/ malignancies, &lt;28 day life expectancy,&#xD;
        Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular&#xD;
        Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure,&#xD;
        Head trauma with Glasgow coma scale score of &lt;5, Immunosuppression: WBC(White Blood Cell&#xD;
        Count) &lt;5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure&#xD;
        with EF(Ejection Fraction) &lt;35%&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Basma Ricaurte, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grace Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grace Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carol Gorbach-Melchioris, MEd, RDNLD</last_name>
      <phone>216-476-2704</phone>
      <email>cgorbach-melchhioris@gracehospital.org</email>
    </contact>
    <investigator>
      <last_name>Basma Ricaurte, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 1, 2014</last_update_submitted>
  <last_update_submitted_qc>August 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</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>Lung Injury</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT02208700
org study id: 1141459
nct id: NCT02208700
lead sponsor: 
collaborator: 
has dmc: No
Patients with mechanical ventilation have shown improved weaning rates when enteral tube
      feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.

      LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical
      ventilation, decreased mortality rates and decreased organ failure when fed an enteral
      product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral
      nutrition product.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of days on mechanical ventilation
time frame: 14 days from start of enteral feeding
arm group label: Oxepa
arm group type: Experimental
description: Other: Therapeutic nutrition with EPA, GLA and antioxidants.
arm group label: Jevity 1.5
arm group type: Active Comparator
description: Other: Jevity 1.5 Complete Balanced Nutrition with Fiber .
intervention type: Other
intervention name: Oxepa
description: Therapeutic nutrition with EPA, GLA< and antioxidants
arm group label: Oxepa
intervention type: Other
intervention name: Jevity 1.5
description: Complete balanced nutrition with a unique fiber blend
arm group label: Jevity 1.5
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Basma Ricaurte, MD
role: Principal Investigator
affiliation: Grace Hospital
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lung Injury
mesh term: Acute Lung Injury