Clinical trial NCT04414410: Echocardiography in Critically-ill Patients With COVID-19 Pneumonia
Official title: Echocardiography in Critically-ill Patients With COVID-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Sars-CoV2
Keywords: critical care echocardiography
COVID
pneumonia
ICU
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID 19 patients admitted in the ICU for respiratory failure.

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/).

Eligibility 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.

-

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

Primary outcomes:
measure: Incidence of Left ventricular systolic dysfunction
timeFrame: Up to 28 days
measure: Incidence of RV failure
timeFrame: up to 28 days
measure: Incidence of Vasoplegia
timeFrame: Up to 28 days
measure: Incidence of Hypovolemia
timeFrame: Up to 28 days
Secondary outcomes:
measure: Relation between plateau pressure and RV failure
timeFrame: Up to 28 days
measure: Relation between tidal volume and RV failure
timeFrame: Up to 28 days
measure: Relation between PaO2 and RV failure
timeFrame: Up to 28 days
measure: Relation between PaCO2 and RV failure
timeFrame: Up to 28 days
measure: Relation between PEEP and RV failure
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: University Hospital Ambroise Pare
state: Hauts De Seine
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Antoine Vieillard-Baron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: