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Clinical Trials/NCT04414410
NCT04414410UnknownNot Applicable

Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

Hospital Ambroise Paré Paris1 site in 1 country1,500 target enrollmentStarted: May 12, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,500
Locations
1
Primary Endpoint
Incidence of Left ventricular systolic dysfunction

Study Overview

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).

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
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Incidence of Left ventricular systolic dysfunction

Time Frame: Up to 28 days

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

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.

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.

Incidence of RV failure

Time Frame: up to 28 days

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

Secondary Outcomes

  • Relation between plateau pressure and RV failure(Up to 28 days)
  • Relation between tidal volume and RV failure(Up to 28 days)
  • Relation between PaO2 and RV failure(Up to 28 days)
  • Relation between PaCO2 and RV failure(Up to 28 days)
  • Relation between PEEP and RV failure(Up to 28 days)

Investigators

Sponsor
Hospital Ambroise Paré Paris
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof Antoine Vieillard-Baron

Professor

Hospital Ambroise Paré Paris

Study Sites (1)

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