Acute Respiratory Distress SyndromeVD-SDRANCT04184674
Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
A study testing Pneumotachograph, Esophageal catheter and Transthoracic and / or transesophageal cardiac ultrasound in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might : i) be… Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Pneumotachograph, Esophageal catheter and Transthoracic and / or transesophageal cardiac ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jun 2020to 11 Jun 2022
- Phase
- Interventional
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over one month
- Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
- Signed consent
Who cannot join
- Neonates less than 28 days-old
- Pregnancy or breastfeeding
- Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
- No social care
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :
- be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.
Read more
The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.
Secondary objectives are :
- to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults. ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
- To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
- To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
Read the detailed description
Acute Respiratory Distress Syndrome (ARDS) is an acute inflammatory lung injury associated with a high pulmonary vascular permeability, leading to acute respiratory failure. Positive pressure mechanical ventilation,improves survival but might lead to ventilator-induced lung injury (VILI) and right ventricular failure. This hemodynamic effect is more important when compliance is decreased, especially in ARDS.
The use of long protective ventilation (with low tidal volumes and low plateau pressures) has improved prognosis of ARDS in adult patients. However, tidal volume and plateau pressures do not always reflect the lung deformation and the stress induced by the ventilation; these variables depend on the characteristics of the patient's respiratory system. Therefore, management focuses on ventilation strategies according to these characteristics.
Among tools used to evaluate respiratory physiological parameters, the esophageal pressure measurement is easily feasible at the bedside, and well estimates pleural pressure and pulmonary distension. During invasive ventilation, transpulmonary pressure (PL) can be obtained with the difference between the airway pressure and the esophageal pressure. Calculation of transpulmonary pressure in ARDS allows optimal ventilator management of adult and children treated for ARDS.
Although individualized ventilation techniques have shown some benefits in ARDS, studies have failed to show that survival could be improved by such strategies. This lack of efficacy could be partly explained by the hemodynamic impact of ventilation-induced pulmonary distension. It therefore seems essential to combine a robust assessment of right ventricular function with measurements of transpulmonary pressure in order to know the real hemodynamic impact of positive pressure ventilation in ARDS in adults and children.
The primary objective is to test the impact of transpulmonary pressure on right ventricular functionin ARDS adults and children.
Secondary objectives are :
- to compare thresholds of transpulmonary pressure associated to right ventricle failure between children and adults ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
- To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
- To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Pneumotachograph, Esophageal catheter, Transthoracic and / or transesophageal cardiac ultrasound, Electrical impedance tomography (EIT) for pediatric patients
- Keywords
- Acute Respiratory Distress Syndrome, Mechanical ventilation, Transpulmonary pressure, Right ventricle failure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumotachographOther
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
- The first measurement will be performed 5 minutes after the initial ventilator settings.
- Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
- An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Esophageal catheterOther
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management
- The first measurement will be performed 5 minutes after the initial ventilator settings.
- Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
- An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Transthoracic and / or transesophageal cardiac ultrasoundOther
The right ventricle systolic function will be assessed thanks to a transthoracic cardiac ultrasound in children, and a transthoracic of a transesophageal cardiac ultrasound in adults :
Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
- The first measurement will be performed 5 minutes after the initial ventilator settings.
- Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
- An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).
Electrical impedance tomography (EIT) for pediatric patientsOther
For pediatric patients: measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management.
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Distress Syndrome | Other | Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome. Receives: Other: Pneumotachograph; Other: Esophageal catheter; Other: Transthoracic and / or transesophageal cardiac ultrasound; Other: Electrical impedance tomography (EIT) for pediatric patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle failure
Right ventricle failure is defined, by ultrasound, as a composite criteria associating :
- end-diastolic right ventricle/left ventricle area ratio > 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia),
- and/or a tricuspid annular plane systolic excursion < 1,6 cm (adults), z-score < -2 (children),
- and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) < 10 cm/s,
- and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) < 35%,
- and/or a peak right ventricle free wall 2D strain < -30% (adults), z-score < 2 (children).
Measured: Three days
Secondary outcomes (13)
Airways pressure
Airways pressure (Paw) will be measured in cmH2O thanks to a pneumotachograph connected to the ventilator.
Measured: Three days
Oesophageal pressure
Esophageal pressure (Pes) will be measured in cmH2O thanks to an oesophageal balloon catheter introduced in the mid-esophagus of the patient and connected to a manometer.
Measured: Three days
Transpulmonary pressure calculation
Measurements will be performed at different moments during the respiratory cycle: after an inspiratory pause to evaluate the tele-inspiratory transpulmonary pressure (PL-insp), and after an expiratory pause to evaluate the tele-expiratory transpulmonary pressure (PL-PEP ). The PL-insp will be calculated using the ratio between the elastance of the chest wall (Ecw) and of the respiratory system (Ers) thanks to this formula PL = Paw - Paw x (Ecw/Ers). The PL-exp will be calculated using the ratio between Paw et Pes (PL = Paw - Pes). Transpulmonary pressure will be expressed in cmH2O.
Measured: Three days
Vaso-Active Inotrope Score (VIS)
Correlation between transpulmonary pressure and morbidity. Vaso-Active Inotrope Score is a hemodynamic score taking into account the cumulative doses of inotropic or vassopressive drugs. It is obtained thanks this calculation : VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10000 x vasopressin dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min). Its value ranges from zero, which is associated to a better outcome, to the maximum cumulative dose without any limit.
Measured: Three days
Duration of treatment with vasoactive or inotropic drugs
Number of days under vaso-active or inotropic drugs
Measured: 3 months after hospitalization in Intensive Care Unit
Pediatric logistic organ dysfunction score
Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).
Measured: Three days
Sepsis-related Organ Function Assessement score
Sepsis-related Organ Function Assessement score is a multiple organ dysfunction score that includes several variables corresponding to 6 organ dysfunctions. Values extend from 0 (best outcome) to 24 (worst outcome).
Measured: Three days
Invasive and non invasive ventilation free days
Number of invasive and non invasive ventilation free days
Measured: 3 months after hospitalization in Intensive Care Unit
Lung and Chest Wall compliance
Lung and chest wall compliances (in mL/cmH2O) will be calculated thanks to the respective ratios tidal volume/(PL-insp - PL-PEP) and tidal volume/(Pes insp - Pes-PEP).
Measured: Three days
Length of hospitalization
Length of hospitalization in Intensive Care Unit and in hospital in days.
Measured: 3 months after hospitalization in Intensive Care Unit
Mortality at 28 days
Death in Intensive Care Unit and at 28 days of hospitalization.
Measured: 28 days
Mortality in Intensive Care Unit
Death in Intensive Care Unit.
Measured: 3 months after hospitalization in Intensive Care Unit
Eletrical impedance tomography
Electrical impedance tomography will be monitored only in children. Several methods will be used and compared, based on e.g. pixel information of lung aeration, to assess end-expiratory lung volume (ELLV, in mL) and the distribution of ventilation
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start11 Jun 2020
- Primary completion11 Jun 2022
- Study completion11 Jun 2022
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Meryl Vedrenne-Cloquet, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisBrigitte Fauroux, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184674
- Sponsor's protocol ID
- APHP191033
- Other IDs
- 2019-A02814-53
- Acronym
- VD-SDRA
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vedrenne-Cloquet M, Petit M, Khirani S, Charron C, Khraiche D, Panaioli E, Habib M, Renolleau S, Fauroux B, Vieillard-Baron A. Impact of the transpulmonary pressure on right ventricle impairment incidence during acute respiratory distress syndrome: a pilot study in adults and children. Intensive Care Med Exp. 2024 Sep 27;12(1):84. doi: 10.1186/s40635-024-00671-2.
PubMed 39331249
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04184674
- Acronym / sponsor ID
- VD-SDRA / APHP191033
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Mechanical ventilation, Transpulmonary pressure, Right ventricle failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 3 Dec 2019 (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.
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :
- be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.
The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.
Secondary objectives are :
- to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults. ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
- To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
- To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
Detailed description
Acute Respiratory Distress Syndrome (ARDS) is an acute inflammatory lung injury associated with a high pulmonary vascular permeability, leading to acute respiratory failure. Positive pressure mechanical ventilation,improves survival but might lead to ventilator-induced lung injury (VILI) and right ventricular failure. This hemodynamic effect is more important when compliance is decreased, especially in ARDS.
The use of long protective ventilation (with low tidal volumes and low plateau pressures) has improved prognosis of ARDS in adult patients. However, tidal volume and plateau pressures do not always reflect the lung deformation and the stress induced by the ventilation; these variables depend on the characteristics of the patient's respiratory system. Therefore, management focuses on ventilation strategies according to these characteristics.
Among tools used to evaluate respiratory physiological parameters, the esophageal pressure measurement is easily feasible at the bedside, and well estimates pleural pressure and pulmonary distension. During invasive ventilation, transpulmonary pressure (PL) can be obtained with the difference between the airway pressure and the esophageal pressure. Calculation of transpulmonary pressure in ARDS allows optimal ventilator management of adult and children treated for ARDS.
Although individualized ventilation techniques have shown some benefits in ARDS, studies have failed to show that survival could be improved by such strategies. This lack of efficacy could be partly explained by the hemodynamic impact of ventilation-induced pulmonary distension. It therefore seems essential to combine a robust assessment of right ventricular function with measurements of transpulmonary pressure in order to know the real hemodynamic impact of positive pressure ventilation in ARDS in adults and children.
The primary objective is to test the impact of transpulmonary pressure on right ventricular functionin ARDS adults and children.
Secondary objectives are :
- to compare thresholds of transpulmonary pressure associated to right ventricle failure between children and adults ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
- To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
- To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Distress Syndrome | Other | Other: Pneumotachograph, Other: Esophageal catheter, Other: Transthoracic and / or transesophageal cardiac ultrasound, Other: Electrical impedance tomography (EIT) for pediatric patientsChildren of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over one month
- Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
- Signed consent
Key exclusion criteria (4 listed)
- Neonates less than 28 days-old
- Pregnancy or breastfeeding
- Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
- No social care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PneumotachographMeasurements will be performed during the first three days of Acute Respiratory Distress Syndrome management : * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures). | Other | Acute Respiratory Distress Syndrome |
| Esophageal catheterMeasurements will be performed during the first three days of Acute Respiratory Distress Syndrome management * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures). | Other | Acute Respiratory Distress Syndrome |
| Transthoracic and / or transesophageal cardiac ultrasoundThe right ventricle systolic function will be assessed thanks to a transthoracic cardiac ultrasound in children, and a transthoracic of a transesophageal cardiac ultrasound in adults : Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management : * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures). | Other | Acute Respiratory Distress Syndrome |
| Electrical impedance tomography (EIT) for pediatric patientsFor pediatric patients: measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management. | Other | Acute Respiratory Distress Syndrome |
Primary outcome
Right ventricle failure
Time frame: Three days
Right ventricle failure is defined, by ultrasound, as a composite criteria associating : * end-diastolic right ventricle/left ventricle area ratio > 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia), * and/or a tricuspid annular plane systolic excursion < 1,6 cm (adults), z-score < -2 (children), * and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) < 10 cm/s, * and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) < 35%, * and/or a peak right ventricle free wall 2D strain < -30% (adults), z-score < 2 (children).
13 secondary outcomes
Airways pressure
Time frame: Three days
Oesophageal pressure
Time frame: Three days
Transpulmonary pressure calculation
Time frame: Three days
Vaso-Active Inotrope Score (VIS)
Time frame: Three days
Duration of treatment with vasoactive or inotropic drugs
Time frame: 3 months after hospitalization in Intensive Care Unit
Pediatric logistic organ dysfunction score
Time frame: Three days
Sepsis-related Organ Function Assessement score
Time frame: Three days
Invasive and non invasive ventilation free days
Time frame: 3 months after hospitalization in Intensive Care Unit
Lung and Chest Wall compliance
Time frame: Three days
Length of hospitalization
Time frame: 3 months after hospitalization in Intensive Care Unit
Mortality at 28 days
Time frame: 28 days
Mortality in Intensive Care Unit
Time frame: 3 months after hospitalization in Intensive Care Unit
Eletrical impedance tomography
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Results publication: PubMed 39331249Vedrenne-Cloquet M, Petit M, Khirani S, Charron C, Khraiche D, Panaioli E, Habib M, Renolleau S, Fauroux B, Vieillard-Baron A. Impact of the transpulmonary pressure on right ventricle impairment incidence during acute respiratory distress syndrome: a pilot study in adults and children. Intensive Care Med Exp. 2024 Sep 27;12(1):84. doi: 10.1186/s40635-024-00671-2.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
Meryl Vedrenne-Cloquet, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Brigitte Fauroux, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumotachograph, Esophageal catheter and Transthoracic and / or transesophageal cardiac ultrasound in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Right ventricle failure (time frame: Three days). 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 NCT04184674, 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 11 Mar 2026.