<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/NCT04480944</url>
  </required_header>
  <id_info>
    <org_study_id>CER2018-02268</org_study_id>
    <nct_id>NCT04480944</nct_id>
  </id_info>
  <brief_title>Massive Burns: Retrospective Analysis of Changes in Outcomes Across 18 Years</brief_title>
  <acronym>MassiveBurns</acronym>
  <official_title>Massive Burns: Retrospective Analysis of Change in Outcomes Across 18 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mette M Berger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</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>
      Burns treatment and management has evolved since the 90s, particularly for massive burns (≥&#xD;
      50% of total body surface area (TBSA)). This study aims at analyzing the impact of the&#xD;
      management changes on the length of intensive care unit (ICU) stay, the take of skin grafts&#xD;
      and the mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Review of all massively burned patients treated at Lausanne University Hospital burn&#xD;
      intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care&#xD;
      unit stay (LICU), skin graft take rate or mortality between 2000 and 2018.&#xD;
&#xD;
      Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined&#xD;
      with the use of novel surgical techniques has brought a significant improvement in outcomes.&#xD;
&#xD;
      Association between outcomes and year of admission will be assessed through correlation&#xD;
      analysis and logistic regression analysis. Potential cofounders will be assessed through&#xD;
      stepwise linear regression analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>LICU/Percent TBSA</measure>
    <time_frame>18 years</time_frame>
    <description>Ratio between the length of stay in the ICU and the total body surface area burned</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent TBSA grafted/ Percent TBSA deep burns</measure>
    <time_frame>18 years</time_frame>
    <description>Ratio between the TBSA grafted and the deep burns TBSA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily nutritional intakes</measure>
    <time_frame>18 years</time_frame>
    <description>Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>18 years</time_frame>
    <description>Percentage of patients who received maximal care and died nonetheless</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Burns</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults patients with extremely large burns (massive burn &gt;50% TBSA) admitted and treated&#xD;
        from beginning to end in the burn intensive care unit of a university hospital burn center&#xD;
        in Switzerland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (&gt;18 years old) with burns ≥50% TBSA admitted in the burn intensive&#xD;
             care unit (ICU) of the Lausanne University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in the burn center ICU with another primary diagnosis than burn&#xD;
             (e.g. necrotizing fasciitis, gangrene, toxic epidermal necrolysis)&#xD;
&#xD;
          -  Patients referred from and/or to another ICU&#xD;
&#xD;
          -  Patients in which active withdrawal of care was decided within 48h of admission&#xD;
&#xD;
          -  Patients with first degree burns only&#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>Wassim Raffoul, MD</last_name>
    <role>Study Director</role>
    <affiliation>CHUV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adult ICU and Burn ICU, Lausanne University Hospital</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Pantet O, Stoecklin P, Vernay A, Berger MM. Impact of decreasing energy intakes in major burn patients: A 15-year retrospective cohort study. Clin Nutr. 2017 Jun;36(3):818-824. doi: 10.1016/j.clnu.2016.05.007. Epub 2016 May 24.</citation>
    <PMID>27256559</PMID>
  </reference>
  <reference>
    <citation>Brusselaers N, Hoste EA, Monstrey S, Colpaert KE, De Waele JJ, Vandewoude KH, Blot SI. Outcome and changes over time in survival following severe burns from 1985 to 2004. Intensive Care Med. 2005 Dec;31(12):1648-53. doi: 10.1007/s00134-005-2819-6. Epub 2005 Oct 12.</citation>
    <PMID>16220315</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Mette M Berger</investigator_full_name>
    <investigator_title>Associate professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Massive burns</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Burn surgery</keyword>
  <keyword>Burn infections</keyword>
  <keyword>Skin grafts</keyword>
  <keyword>Critical illness</keyword>
  <keyword>Cultured epithelial autografts</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Glucose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</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/NCT04480944
org study id: CER2018-02268
nct id: NCT04480944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burns treatment and management has evolved since the 90s, particularly for massive burns (≥
      50% of total body surface area (TBSA)). This study aims at analyzing the impact of the
      management changes on the length of intensive care unit (ICU) stay, the take of skin grafts
      and the mortality.
Review of all massively burned patients treated at Lausanne University Hospital burn
      intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care
      unit stay (LICU), skin graft take rate or mortality between 2000 and 2018.

      Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined
      with the use of novel surgical techniques has brought a significant improvement in outcomes.

      Association between outcomes and year of admission will be assessed through correlation
      analysis and logistic regression analysis. Potential cofounders will be assessed through
      stepwise linear regression analysis
observational model: Cohort
time perspective: Retrospective
measure: LICU/Percent TBSA
time frame: 18 years
description: Ratio between the length of stay in the ICU and the total body surface area burned
measure: Percent TBSA grafted/ Percent TBSA deep burns
time frame: 18 years
description: Ratio between the TBSA grafted and the deep burns TBSA
measure: Daily nutritional intakes
time frame: 18 years
description: Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight
measure: Mortality
time frame: 18 years
description: Percentage of patients who received maximal care and died nonetheless
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wassim Raffoul, MD
role: Study Director
affiliation: CHUV
facility: 
country: Switzerland
citation: Pantet O, Stoecklin P, Vernay A, Berger MM. Impact of decreasing energy intakes in major burn patients: A 15-year retrospective cohort study. Clin Nutr. 2017 Jun;36(3):818-824. doi: 10.1016/j.clnu.2016.05.007. Epub 2016 May 24.
PMID: 27256559
citation: Brusselaers N, Hoste EA, Monstrey S, Colpaert KE, De Waele JJ, Vandewoude KH, Blot SI. Outcome and changes over time in survival following severe burns from 1985 to 2004. Intensive Care Med. 2005 Dec;31(12):1648-53. doi: 10.1007/s00134-005-2819-6. Epub 2005 Oct 12.
PMID: 16220315
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Mette M Berger
investigator title: Associate professor, MD, PhD
mesh term: Burns
sharing ipd: No