<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/NCT02189538</url>
  </required_header>
  <id_info>
    <org_study_id>Universidad de la República</org_study_id>
    <nct_id>NCT02189538</nct_id>
  </id_info>
  <brief_title>Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients</brief_title>
  <acronym>OmegaBurn</acronym>
  <official_title>Effect of Omega-3 PUFA From Fish in Major Burn Patients. EFECTO DE ÁCIDOS GRASOS POLIINSATURADOS OMEGA 3 DERIVADOS DE ACEITE DE PESCADO, EN QUEMADOS GRAVES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Nacional de Quemados, Uruguay</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Nacional de Quemados, Uruguay</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that burn patients may benefit from low fat diets, but there is still no&#xD;
      strong data regarding the impact of fatty acid composition used for feeding. The trial test&#xD;
      the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome.&#xD;
      Prospective randomised controlled trial in adult patients admitted for burns &gt; 15% body&#xD;
      surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral&#xD;
      nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular&#xD;
      enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study&#xD;
      endpoints: mechanical ventilation time, inflammation (CRP), infectious and other&#xD;
      complications, mortality until discharge.&#xD;
&#xD;
      The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2)&#xD;
      the study completed with information from the preliminary phase, both phases being randomised&#xD;
      and controlled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA&#xD;
      (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing&#xD;
      solution.&#xD;
&#xD;
      The patients are fed as long as clinically required with the initial solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of infections</measure>
    <time_frame>up to Day 28 after burn injury</time_frame>
    <description>Infectious complications will be recorded according to CDC criteria, and grouped as pulmonary, blood stream infections (catheter related or not), cutaneous, abdominal and others</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non infectious complications</measure>
    <time_frame>up to day 28</time_frame>
    <description>Any complication will be recorded during the above time frame</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>up to day 28</time_frame>
    <description>Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy)</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of ICU and hospital stay</measure>
    <time_frame>up to day 28</time_frame>
    <description>ICU and hospital to discharge but maximum for 28 days</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>Hospital stay</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Magnitude of CRP increase</measure>
    <time_frame>during ICU stay and up to day 28</time_frame>
    <description>C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Burn Injury</condition>
  <arm_group>
    <arm_group_label>ω-3 PUFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modular low fat diet (18%) including 9% as ω-3 PUFA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low fat enteral diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Modular low fat (18%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ω-3 PUFA</intervention_name>
    <description>The patients are fed as long as the clinically required with the randomly attributed enteral solution.</description>
    <arm_group_label>ω-3 PUFA</arm_group_label>
    <other_name>modular preparation: 9% ω-3 of the total 18% fat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low fat enteral diet</intervention_name>
    <description>The patients are fed as long as the clinically required with the randomly attributed enteral solution</description>
    <arm_group_label>Low fat enteral diet</arm_group_label>
    <other_name>modular diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - adult &gt;16 years, burns &gt; 15% BSA, mechanical ventilation, next of kin consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absence of the above, absence of commitment to full treatment&#xD;
&#xD;
          -  comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serrana Tihista, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de la República Oriental del Uruguay</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro National de Quemados</name>
      <address>
        <city>Montevideo</city>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serrana Tihista, RD</last_name>
      <phone>(598) 2613 35 63</phone>
      <email>serranatihista@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Serrana Tihista, RD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julio Roberto Cabrera Martin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Uruguay</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Nacional de Quemados, Uruguay</investigator_affiliation>
    <investigator_full_name>Serrana Tihista</investigator_full_name>
    <investigator_title>dietitian</investigator_title>
  </responsible_party>
  <keyword>Infections, Enteral nutrition, SIRS, critically ill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</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/NCT02189538
org study id: Universidad de la República
nct id: NCT02189538
lead sponsor: 
has dmc: No
Studies have shown that burn patients may benefit from low fat diets, but there is still no
      strong data regarding the impact of fatty acid composition used for feeding. The trial test
      the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome.
      Prospective randomised controlled trial in adult patients admitted for burns > 15% body
      surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral
      nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular
      enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study
      endpoints: mechanical ventilation time, inflammation (CRP), infectious and other
      complications, mortality until discharge.

      The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2)
      the study completed with information from the preliminary phase, both phases being randomised
      and controlled.
Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA
      (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing
      solution.

      The patients are fed as long as clinically required with the initial solution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Number of infections
time frame: up to Day 28 after burn injury
description: Infectious complications will be recorded according to CDC criteria, and grouped as pulmonary, blood stream infections (catheter related or not), cutaneous, abdominal and others
measure: Non infectious complications
time frame: up to day 28
description: Any complication will be recorded during the above time frame
measure: Duration of mechanical ventilation
time frame: up to day 28
description: Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy)
measure: Length of ICU and hospital stay
time frame: up to day 28
description: ICU and hospital to discharge but maximum for 28 days
measure: Mortality
time frame: Hospital stay
measure: Magnitude of CRP increase
time frame: during ICU stay and up to day 28
description: C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes
arm group label: ω-3 PUFA
arm group type: Experimental
description: Modular low fat diet (18%) including 9% as ω-3 PUFA
arm group label: Low fat enteral diet
arm group type: Active Comparator
description: Modular low fat (18%)
intervention type: Dietary Supplement
intervention name: ω-3 PUFA
description: The patients are fed as long as the clinically required with the randomly attributed enteral solution.
arm group label: ω-3 PUFA
other name: modular preparation: 9% ω-3 of the total 18% fat
intervention type: Dietary Supplement
intervention name: Low fat enteral diet
description: The patients are fed as long as the clinically required with the randomly attributed enteral solution
arm group label: Low fat enteral diet
other name: modular diet
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Serrana Tihista, RD
role: Principal Investigator
affiliation: Universidad de la República Oriental del Uruguay
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Uruguay
responsible party type: Principal Investigator
investigator affiliation: Centro Nacional de Quemados, Uruguay
investigator full name: Serrana Tihista
investigator title: dietitian
mesh term: Burns