<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/NCT03271268</url>
  </required_header>
  <id_info>
    <org_study_id>StLouisFrance</org_study_id>
    <nct_id>NCT03271268</nct_id>
  </id_info>
  <brief_title>Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients</brief_title>
  <acronym>CAROLE</acronym>
  <official_title>The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint-Louis Hospital, Paris, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint-Louis Hospital, Paris, France</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>
      Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the&#xD;
      cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to&#xD;
      fluid overload, which manifests most notably as lung edema.&#xD;
&#xD;
      The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well&#xD;
      as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular&#xD;
      congestion, may help identifying patients with risk of pulmonary edema and hypoxia .&#xD;
&#xD;
      Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in&#xD;
      severe burns patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 6, 2017</start_date>
  <completion_date type="Anticipated">April 6, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 6, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lung edema</measure>
    <time_frame>During the first 7 days of admission</time_frame>
    <description>Extravascular lung water (EVLW) &gt; 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoxemia</measure>
    <time_frame>During the first 7 days of admission for mechanically-ventilated patients</time_frame>
    <description>PaO2/FiO2 ratio of &lt;200</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypercapnia</measure>
    <time_frame>During the first 7 days of admission for mechanically-ventilated patients</time_frame>
    <description>PaCO2&gt; 45 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected minute ventilation &gt; 10L/min</measure>
    <time_frame>During the first 7 days of admission for mechanically-ventilated patients</time_frame>
    <description>Minute ventilation × partial [Paco2]/40) &gt; 10L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple organ dysfunction syndrome (MODS)</measure>
    <time_frame>During the first 7 days of admission</time_frame>
    <description>Sequential Organ Failure Assessment score (SOFA) ≥ 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the ICU</measure>
    <time_frame>until 90 days of hospitalization</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Burns</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum bank : 1 sample (5 ml of blood): on admission and from day 1 to day 7 of admission.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Severely ill burn patients admitted to a tertiary referral burn center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intubated mechanically-ventilated patients within the first 24 hours of admission&#xD;
&#xD;
          -  And/or patients with total body surface area (TBSA) burn-injured &gt;20 %&#xD;
&#xD;
          -  And/or patients with at least 10% full-thickness burns&#xD;
&#xD;
          -  And/or receiving vasopressors within the first 24 hours of admission&#xD;
&#xD;
          -  And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission delay to ICU &gt; 24 hours post burn&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic renal impairment with a baseline eGFR &lt; 15 ml/min&#xD;
&#xD;
          -  Patients with chemical or electrical burns&#xD;
&#xD;
          -  Coexisting non-burn trauma&#xD;
&#xD;
          -  Patients moribund on admission or dead within 72 h from admission&#xD;
&#xD;
          -  Patients with do-not-resuscitate orders&#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>Sabri Soussi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint-Louis Hospital, Paris, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sabri Soussi, MD</last_name>
    <phone>0613064542</phone>
    <phone_ext>+33</phone_ext>
    <email>sabri.soussi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu Legrand, MD, PhD</last_name>
    <phone>0685104235</phone>
    <phone_ext>+33</phone_ext>
    <email>matthieu.m.legrand@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sabri SOUSSI</name>
      <address>
        <city>Paris</city>
        <state>Ile de France</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabri Soussi, MD</last_name>
      <phone>0613064542</phone>
      <phone_ext>+33</phone_ext>
      <email>sabri.soussi@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Matthieu Legrand, MD, PhD</last_name>
      <phone>0685104235</phone>
      <phone_ext>+33</phone_ext>
      <email>matthieu.m.legrand@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Soluble+CD146%2C+a+new+endothelial+biomarker+of+acutely+decompensated+heart+failure</url>
    <description>Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/23425748</url>
    <description>Natriuretic peptide type B in burn intensive care</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Plasma+Levels+of+Soluble+CD146+Reflect+the+Severity+of+Pulmonary+Congestion+Better+Than+Brain+Natriuretic+Peptide+in+Acute+Coronary+Syndrome</url>
    <description>Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary Syndrome</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint-Louis Hospital, Paris, France</investigator_affiliation>
    <investigator_full_name>Sabri SOUSSI</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Vascular filling</keyword>
  <keyword>Fluid overload</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Lung edema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Edema</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/NCT03271268
org study id: StLouisFrance
nct id: NCT03271268
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the
      cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to
      fluid overload, which manifests most notably as lung edema.

      The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well
      as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular
      congestion, may help identifying patients with risk of pulmonary edema and hypoxia .

      Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in
      severe burns patients.
observational model: Cohort
time perspective: Prospective
measure: Lung edema
time frame: During the first 7 days of admission
description: Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)
measure: Hypoxemia
time frame: During the first 7 days of admission for mechanically-ventilated patients
description: PaO2/FiO2 ratio of <200
measure: Hypercapnia
time frame: During the first 7 days of admission for mechanically-ventilated patients
description: PaCO2> 45 mmHg
measure: Corrected minute ventilation > 10L/min
time frame: During the first 7 days of admission for mechanically-ventilated patients
description: Minute ventilation × partial [Paco2]/40) > 10L/min
measure: Multiple organ dysfunction syndrome (MODS)
time frame: During the first 7 days of admission
description: Sequential Organ Failure Assessment score (SOFA) ≥ 8
measure: 28-day mortality
time frame: 28 days
measure: 90-day mortality
time frame: 90 days
measure: Length of stay in the ICU
time frame: until 90 days of hospitalization
Serum bank : 1 sample (5 ml of blood): on admission and from day 1 to day 7 of admission.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sabri Soussi, MD
role: Principal Investigator
affiliation: Saint-Louis Hospital, Paris, France
last name: Sabri Soussi, MD
phone: 0613064542
phone ext: +33
email: sabri.soussi@gmail.com
last name: Matthieu Legrand, MD, PhD
phone: 0685104235
phone ext: +33
email: matthieu.m.legrand@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Soluble+CD146%2C+a+new+endothelial+biomarker+of+acutely+decompensated+heart+failure
description: Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure
url: https://www.ncbi.nlm.nih.gov/pubmed/23425748
description: Natriuretic peptide type B in burn intensive care
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Plasma+Levels+of+Soluble+CD146+Reflect+the+Severity+of+Pulmonary+Congestion+Better+Than+Brain+Natriuretic+Peptide+in+Acute+Coronary+Syndrome
description: Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary Syndrome
responsible party type: Principal Investigator
investigator affiliation: Saint-Louis Hospital, Paris, France
investigator full name: Sabri SOUSSI
investigator title: MD
mesh term: Pulmonary Edema
sharing ipd: No