ECHO-COVID: Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

Sponsor
Hospital Ambroise Paré Paris (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04414410
Collaborator
(none)
1,500
1
16.6
90.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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/).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Echocardiography in Critically-ill Patients With COVID-19 Pneumonia
    Actual Study Start Date :
    May 12, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2021
    Anticipated Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Left ventricular systolic dysfunction [Up to 28 days]

      LV systolic dysfunction is defined as an ejection fraction < 45%

    2. Incidence of RV failure [up to 28 days]

      RV failure is defined as RV/LV end-diastolic area > 0.8

    3. Incidence of Vasoplegia [Up to 28 days]

      Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.

    4. Incidence of Hypovolemia [Up to 28 days]

      Hypovolemia is defined as inspiratory collaspe of the superior vena cava in ventilated patients or virtual inferior vena cava in spontaneously breathing patients.

    Secondary Outcome Measures

    1. Relation between plateau pressure and RV failure [Up to 28 days]

      Plateau pressure and RV size

    2. Relation between tidal volume and RV failure [Up to 28 days]

      Tidal volume and RV size

    3. Relation between PaO2 and RV failure [Up to 28 days]

      PaO2, PaO2/FiO2, and RV size

    4. Relation between PaCO2 and RV failure [Up to 28 days]

      PaCO2 and RV size

    5. Relation between PEEP and RV failure [Up to 28 days]

      PEEP and RV size

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All

    Inclusion Criteria: patients admitted in the ICU for pneumonia related to SARS COV2 and who had at least 1 critical care echocardiography during the first 28 days.

    -

    Exclusion Criteria: Patients who did not have any critical care echocardiography during the first 28 days of the ICU stay.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Ambroise Pare Boulogne-Billancourt Hauts De Seine France 92100

    Sponsors and Collaborators

    • Hospital Ambroise Paré Paris

    Investigators

    • Principal Investigator: Antoine Vieillard-Baron, MD, PhD, Hospital Ambroise Paré Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof Antoine Vieillard-Baron, Professor, Hospital Ambroise Paré Paris
    ClinicalTrials.gov Identifier:
    NCT04414410
    Other Study ID Numbers:
    • RedCap19
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Apr 29, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof Antoine Vieillard-Baron, Professor, Hospital Ambroise Paré Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2021