- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414410
Echocardiography in Critically-ill Patients With COVID-19 Pneumonia (ECHO-COVID)
April 28, 2021 updated by: Prof Antoine Vieillard-Baron, Hospital Ambroise Paré Paris
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).
Study Overview
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 Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hauts De Seine
-
Boulogne-Billancourt, Hauts De Seine, France, 92100
- University Hospital Ambroise Pare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COVID 19 patients admitted in the ICU for respiratory failure.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Left ventricular systolic dysfunction
Time Frame: Up to 28 days
|
LV systolic dysfunction is defined as an ejection fraction < 45%
|
Up to 28 days
|
Incidence of RV failure
Time Frame: up to 28 days
|
RV failure is defined as RV/LV end-diastolic area > 0.8
|
up to 28 days
|
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.
|
Up to 28 days
|
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.
|
Up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relation between plateau pressure and RV failure
Time Frame: Up to 28 days
|
Plateau pressure and RV size
|
Up to 28 days
|
Relation between tidal volume and RV failure
Time Frame: Up to 28 days
|
Tidal volume and RV size
|
Up to 28 days
|
Relation between PaO2 and RV failure
Time Frame: Up to 28 days
|
PaO2, PaO2/FiO2, and RV size
|
Up to 28 days
|
Relation between PaCO2 and RV failure
Time Frame: Up to 28 days
|
PaCO2 and RV size
|
Up to 28 days
|
Relation between PEEP and RV failure
Time Frame: Up to 28 days
|
PEEP and RV size
|
Up to 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoine Vieillard-Baron, MD, PhD, Hospital Ambroise Paré Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2020
Primary Completion (Anticipated)
September 30, 2021
Study Completion (Anticipated)
September 30, 2021
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
April 29, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RedCap19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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