<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/NCT04414410</url>
  </required_header>
  <id_info>
    <org_study_id>RedCap19</org_study_id>
    <nct_id>NCT04414410</nct_id>
  </id_info>
  <brief_title>Echocardiography in Critically-ill Patients With COVID-19 Pneumonia</brief_title>
  <acronym>ECHO-COVID</acronym>
  <official_title>Echocardiography in Critically-ill Patients With COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Ambroise Paré Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Ambroise Paré Paris</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>
      Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid&#xD;
      outbreak leads that many patients with acute respiratory failure were admitted in the ICU.&#xD;
      Many of these patients were ventilated and developed ARDS. Some of them developed deep vein&#xD;
      thrombosis and pulmonary embolism. Nothing is already described about the cardiac function&#xD;
      and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...).&#xD;
      The echo group of the cardiodynamix section of European society of intensive care medicien&#xD;
      (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively&#xD;
      enter in an international database all the echo studies done as usual care in these patients&#xD;
      to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii)&#xD;
      incidence of other patterns. Another objective will be to look for any association between&#xD;
      some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo&#xD;
      studies were done and will be reported following one of the recent systematic review&#xD;
      published by the same group (Huang S et al. AOIC 2020).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter, international observational retrospective study. Patients admitted in the ICU&#xD;
      between March 1th and april 26th for a pneumonia related to SARS COV 2 and who had at least&#xD;
      one echocardiography during their stay will be included. Analysis will be retrospective in&#xD;
      order to report the hemodynamic profile with left ventricular and right ventricular function.&#xD;
      Will be also reported the respiratory settings, the central venous presure if available as&#xD;
      well as usual parameters of macrocirculation. All data will be reported in RedCap by the&#xD;
      University of sydney (https://redcap.sydney.edu.au/).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</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 Left ventricular systolic dysfunction</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>LV systolic dysfunction is defined as an ejection fraction &lt; 45%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of RV failure</measure>
    <time_frame>up to 28 days</time_frame>
    <description>RV failure is defined as RV/LV end-diastolic area &gt; 0.8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Vasoplegia</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Hypovolemia</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Hypovolemia is defined as inspiratory collaspe of the superior vena cava in ventilated patients or virtual inferior vena cava in spontaneously breathing patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relation between plateau pressure and RV failure</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Plateau pressure and RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between tidal volume and RV failure</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Tidal volume and RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between PaO2 and RV failure</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>PaO2, PaO2/FiO2, and RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between PaCO2 and RV failure</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>PaCO2 and RV size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between PEEP and RV failure</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>PEEP and RV size</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        COVID 19 patients admitted in the ICU for respiratory failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: patients admitted in the ICU for pneumonia related to SARS COV2 and who&#xD;
        had at least 1 critical care echocardiography during the first 28 days.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Patients who did not have any critical care echocardiography during the&#xD;
        first 28 days of the ICU stay.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Antoine Vieillard-Baron, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Ambroise Paré Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ambroise Pare</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <state>Hauts De Seine</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Ambroise Paré Paris</investigator_affiliation>
    <investigator_full_name>Prof Antoine Vieillard-Baron</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>critical care echocardiography</keyword>
  <keyword>COVID</keyword>
  <keyword>pneumonia</keyword>
  <keyword>ICU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT04414410
org study id: RedCap19
nct id: NCT04414410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid
      outbreak leads that many patients with acute respiratory failure were admitted in the ICU.
      Many of these patients were ventilated and developed ARDS. Some of them developed deep vein
      thrombosis and pulmonary embolism. Nothing is already described about the cardiac function
      and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...).
      The echo group of the cardiodynamix section of European society of intensive care medicien
      (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively
      enter in an international database all the echo studies done as usual care in these patients
      to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii)
      incidence of other patterns. Another objective will be to look for any association between
      some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo
      studies were done and will be reported following one of the recent systematic review
      published by the same group (Huang S et al. AOIC 2020).
Multicenter, international observational retrospective study. Patients admitted in the ICU
      between March 1th and april 26th for a pneumonia related to SARS COV 2 and who had at least
      one echocardiography during their stay will be included. Analysis will be retrospective in
      order to report the hemodynamic profile with left ventricular and right ventricular function.
      Will be also reported the respiratory settings, the central venous presure if available as
      well as usual parameters of macrocirculation. All data will be reported in RedCap by the
      University of sydney (https://redcap.sydney.edu.au/).
observational model: Cohort
time perspective: Retrospective
measure: Incidence of Left ventricular systolic dysfunction
time frame: Up to 28 days
description: LV systolic dysfunction is defined as an ejection fraction < 45%
measure: Incidence of RV failure
time frame: up to 28 days
description: RV failure is defined as RV/LV end-diastolic area > 0.8
measure: Incidence of Vasoplegia
time frame: Up to 28 days
description: Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.
measure: Incidence of Hypovolemia
time frame: Up to 28 days
description: Hypovolemia is defined as inspiratory collaspe of the superior vena cava in ventilated patients or virtual inferior vena cava in spontaneously breathing patients.
measure: Relation between plateau pressure and RV failure
time frame: Up to 28 days
description: Plateau pressure and RV size
measure: Relation between tidal volume and RV failure
time frame: Up to 28 days
description: Tidal volume and RV size
measure: Relation between PaO2 and RV failure
time frame: Up to 28 days
description: PaO2, PaO2/FiO2, and RV size
measure: Relation between PaCO2 and RV failure
time frame: Up to 28 days
description: PaCO2 and RV size
measure: Relation between PEEP and RV failure
time frame: Up to 28 days
description: PEEP and RV size
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Antoine Vieillard-Baron, MD, PhD
role: Principal Investigator
affiliation: Hospital Ambroise Paré Paris
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hospital Ambroise Paré Paris
investigator full name: Prof Antoine Vieillard-Baron
investigator title: Professor
mesh term: Pneumonia