Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

COVID Clinical Trial

— ECHO-COVID  

Official title:

Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04414410
• Other study ID #: RedCap19
• Status: Enrolling by invitation
• Start date: May 12, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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/).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• Pneumonia
• Sars-CoV2

Locations

Country	Name	City	State
France	University Hospital Ambroise Pare	Boulogne-Billancourt	Hauts De Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Left ventricular systolic dysfunction	LV systolic dysfunction is defined as an ejection fraction < 45%	Up to 28 days
Primary	Incidence of RV failure	RV failure is defined as RV/LV end-diastolic area > 0.8	up to 28 days
Primary	Incidence of Vasoplegia	Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.	Up to 28 days
Primary	Incidence of Hypovolemia	Hypovolemia is defined as inspiratory collaspe of the superior vena cava in ventilated patients or virtual inferior vena cava in spontaneously breathing patients.	Up to 28 days
Secondary	Relation between plateau pressure and RV failure	Plateau pressure and RV size	Up to 28 days
Secondary	Relation between tidal volume and RV failure	Tidal volume and RV size	Up to 28 days
Secondary	Relation between PaO2 and RV failure	PaO2, PaO2/FiO2, and RV size	Up to 28 days
Secondary	Relation between PaCO2 and RV failure	PaCO2 and RV size	Up to 28 days
Secondary	Relation between PEEP and RV failure	PEEP and RV size	Up to 28 days