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Echocardiography in Critically-ill Patients With COVID-19 Pneumonia (ECHO-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414410
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Antoine Vieillard-Baron, Hospital Ambroise Paré Paris

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
COVID Sars-CoV2

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/).

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Incidence of Left ventricular systolic dysfunction [ Time Frame: Up to 28 days ]
    LV systolic dysfunction is defined as an ejection fraction < 45%

  2. Incidence of RV failure [ Time Frame: up to 28 days ]
    RV failure is defined as RV/LV end-diastolic area > 0.8

  3. Incidence of Vasoplegia [ Time Frame: Up to 28 days ]
    Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.

  4. Incidence of Hypovolemia [ Time Frame: 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 [ Time Frame: Up to 28 days ]
    Plateau pressure and RV size

  2. Relation between tidal volume and RV failure [ Time Frame: Up to 28 days ]
    Tidal volume and RV size

  3. Relation between PaO2 and RV failure [ Time Frame: Up to 28 days ]
    PaO2, PaO2/FiO2, and RV size

  4. Relation between PaCO2 and RV failure [ Time Frame: Up to 28 days ]
    PaCO2 and RV size

  5. Relation between PEEP and RV failure [ Time Frame: Up to 28 days ]
    PEEP and RV size



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
COVID 19 patients admitted in the ICU for respiratory failure.
Criteria

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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414410


Locations
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France
University Hospital Ambroise Pare
Boulogne-Billancourt, Hauts De Seine, France, 92100
Sponsors and Collaborators
Hospital Ambroise Paré Paris
Investigators
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Principal Investigator: Antoine Vieillard-Baron, MD, PhD Hospital Ambroise Paré Paris
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Responsible Party: Prof Antoine Vieillard-Baron, Professor, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT04414410    
Other Study ID Numbers: RedCap19
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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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, Hospital Ambroise Paré Paris:
critical care echocardiography
COVID
pneumonia
ICU
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections