<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/NCT03807232</url>
  </required_header>
  <id_info>
    <org_study_id>ARDS in Burn Patients USZ</org_study_id>
    <nct_id>NCT03807232</nct_id>
  </id_info>
  <brief_title>Predictive Factors, Demographics and Mortality for ARDS in Burn Patients</brief_title>
  <official_title>Predictive Factors, Demographics and Mortality for ARDS in Burn Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      This retrospective study characterizes the clinical course and identifies four independent&#xD;
      predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS;&#xD;
      pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS&#xD;
      burn score), which was derived from these independent predictors. The newly developed score&#xD;
      may be helpful for the development of specific treatment strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a&#xD;
      severe complication associated with a mortality of up to 44%. To date, only few studies have&#xD;
      been published on the clinical course and predictive factors of pbARDS.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To characterize the clinical course of pbARDS, to identify relevant predictors, including the&#xD;
      development of a prognostic score, and to examine outcome parameters such as mortality and&#xD;
      hospitalization days.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the&#xD;
      University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression&#xD;
      was used to determine independent risk factors for pbARDS. A prognostic score was developed,&#xD;
      which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic&#xD;
      (ROC) curves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2010</start_date>
  <completion_date type="Actual">May 23, 2013</completion_date>
  <primary_completion_date type="Actual">May 23, 2013</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>Incidence of post-burn ARDS</measure>
    <time_frame>6 years</time_frame>
    <description>Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical course of post-burn-ARDS</measure>
    <time_frame>6 years</time_frame>
    <description>various clinical parameters related to the Outcome of post-burn-ARDS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>predictors of post-burn ARDS</measure>
    <time_frame>6 years</time_frame>
    <description>To identify relevant predictors of post-burn ARDS, including the development of a prognostic score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>to examine outcome parameter mortality</measure>
    <time_frame>6 years</time_frame>
    <description>A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>to examine outcome parameter hospital stay</measure>
    <time_frame>6 years</time_frame>
    <description>A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>ARDS, Human</condition>
  <condition>Burns</condition>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>pbARDS</arm_group_label>
    <description>Burn patients who developed post-burn ARDS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No pbARDS</arm_group_label>
    <description>Burn patients without development of post-burn ARDS</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital&#xD;
        Zurich (USZ) between January 2004 and December 2009&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital&#xD;
        Zurich (USZ) between January 2004 and December 2009.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusions were made because of incomplete or unavailable data, re-hospitalization due to&#xD;
        complications of previous burns, and the initial decision not to resuscitate due to&#xD;
        unfavorable prognosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pietro Giovanoli, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsspital Zürich</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ARDS, Human</keyword>
  <keyword>Burns</keyword>
  <keyword>Lung Diseases</keyword>
  <keyword>Risk Factors</keyword>
  <keyword>Retrospective Studies</keyword>
  <keyword>Decision Support Techniques</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <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/NCT03807232
org study id: ARDS in Burn Patients USZ
nct id: NCT03807232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study characterizes the clinical course and identifies four independent
      predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS;
      pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS
      burn score), which was derived from these independent predictors. The newly developed score
      may be helpful for the development of specific treatment strategies.
Rationale:

      Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a
      severe complication associated with a mortality of up to 44%. To date, only few studies have
      been published on the clinical course and predictive factors of pbARDS.

      Objectives:

      To characterize the clinical course of pbARDS, to identify relevant predictors, including the
      development of a prognostic score, and to examine outcome parameters such as mortality and
      hospitalization days.

      Methods:

      A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the
      University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression
      was used to determine independent risk factors for pbARDS. A prognostic score was developed,
      which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic
      (ROC) curves.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of post-burn ARDS
time frame: 6 years
description: Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich
measure: Clinical course of post-burn-ARDS
time frame: 6 years
description: various clinical parameters related to the Outcome of post-burn-ARDS
measure: predictors of post-burn ARDS
time frame: 6 years
description: To identify relevant predictors of post-burn ARDS, including the development of a prognostic score
measure: to examine outcome parameter mortality
time frame: 6 years
description: A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich
measure: to examine outcome parameter hospital stay
time frame: 6 years
description: A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich
arm group label: pbARDS
description: Burn patients who developed post-burn ARDS
arm group label: No pbARDS
description: Burn patients without development of post-burn ARDS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Pietro Giovanoli, Prof. Dr. med.
role: Study Chair
affiliation: Universitätsspital Zürich
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Respiratory Distress Syndrome
mesh term: Burns
sharing ipd: No