COVIDECHO-COVIDNCT04414410
Echocardiography in Critically-ill Patients With COVID-19 Pneumonia
An observational study of COVID and Sars-CoV2, run by Hospital Ambroise Paré Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: COVID 19 patients admitted in the ICU for respiratory failure.
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.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Ambroise Pare
Boulogne-Billancourt, Hauts De Seine, 92100
About this study
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).
Read the 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/).
- Keywords
- critical care echocardiography, COVID, pneumonia, ICU
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Left ventricular systolic dysfunction
LV systolic dysfunction is defined as an ejection fraction < 45%
Measured: Up to 28 days
Incidence of RV failure
RV failure is defined as RV/LV end-diastolic area > 0.8
Measured: up to 28 days
Incidence of Vasoplegia
Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.
Measured: Up to 28 days
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.
Measured: Up to 28 days
Secondary outcomes (5)
Relation between plateau pressure and RV failure
Plateau pressure and RV size
Measured: Up to 28 days
Relation between tidal volume and RV failure
Tidal volume and RV size
Measured: Up to 28 days
Relation between PaO2 and RV failure
PaO2, PaO2/FiO2, and RV size
Measured: Up to 28 days
Relation between PaCO2 and RV failure
PaCO2 and RV size
Measured: Up to 28 days
Relation between PEEP and RV failure
PEEP and RV size
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start12 May 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Antoine Vieillard-Baron, Hospital Ambroise Paré Paris
- Investigators
- Antoine Vieillard-Baron, MD, PhD, Principal investigator, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414410
- Sponsor's protocol ID
- RedCap19
- Acronym
- ECHO-COVID
- Status last verified
- Apr 2021
- First submitted
- 27 May 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Vieillard-Baron A, Evrard B, Prat G, Chew MS, Balik M, Clau-Terre F, De Backer D, Mekontso Dessap A, Orde S, Morelli A, Sanfilippo F, Charron C, Vignon P; ECHO-COVID study group. Echocardiography phenotypes of right ventricular involvement in COVID-19 ARDS patients and ICU mortality: post-hoc (exploratory) analysis of repeated data from the ECHO-COVID study. Intensive Care Med. 2023 Aug;49(8):946-956. doi: 10.1007/s00134-023-07147-z. Epub 2023 Jul 12.
PubMed 37436445
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography in Critically-ill Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04414410
- Acronym / sponsor ID
- ECHO-COVID / RedCap19
- Keywords
- critical care echocardiography, COVID, pneumonia, ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- COVID 19 patients admitted in the ICU for respiratory failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Left ventricular systolic dysfunction
Time frame: Up to 28 days
LV systolic dysfunction is defined as an ejection fraction < 45%
Incidence of RV failure
Time frame: up to 28 days
RV failure is defined as RV/LV end-diastolic area > 0.8
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.
5 secondary outcomes
Relation between plateau pressure and RV failure
Time frame: Up to 28 days
Relation between tidal volume and RV failure
Time frame: Up to 28 days
Relation between PaO2 and RV failure
Time frame: Up to 28 days
Relation between PaCO2 and RV failure
Time frame: Up to 28 days
Relation between PEEP and RV failure
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 37436445Huang S, Vieillard-Baron A, Evrard B, Prat G, Chew MS, Balik M, Clau-Terre F, De Backer D, Mekontso Dessap A, Orde S, Morelli A, Sanfilippo F, Charron C, Vignon P; ECHO-COVID study group. Echocardiography phenotypes of right ventricular involvement in COVID-19 ARDS patients and ICU mortality: post-hoc (exploratory) analysis of repeated data from the ECHO-COVID study. Intensive Care Med. 2023 Aug;49(8):946-956. doi: 10.1007/s00134-023-07147-z. Epub 2023 Jul 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Vieillard-Baron, MD, PhD principal investigator
Hospital Ambroise Paré Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Sars-CoV2, run by Hospital Ambroise Paré Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Left ventricular systolic dysfunction (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.