An observational study in Acute Respiratory Distress Syndrome and Right Heart Failure, sponsored by Bicetre Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Bicetre Hospital · Observational
Acute respiratory distress syndrome (ARDS) is an inflammatory injury of the lungs caused by various serious illnesses, such as a bacterial or viral lung infection. It is treated by artificial ventilation with the application of positive pressure. Pulmonary injury, coupled with artificial ventilation, can lead to right heart failure which hinders the ejection of blood to the pulmonary circulation. Modern mechanical ventilation modalities have reduced the frequency ("incidence") of this right heart failure in acute respiratory distress syndrome. A large-scale study has shown this a few years ago. However, the evolution of right heart failure during artificial ventilation, and the consequences it has on the patient's cardiovascular status are poorly determined. This study is conducted to improve knowledge in this area. In adult patients hospitalized in intensive care presenting acute respiratory distress syndrome, the investigators will collect the data recorded on cardiac ultrasound, doses of cardiovascular drugs as well as variables reflecting hemodynamic status and cell oxygenation. Data will be collected during the course of ARDS and mechanical ventilation, as well as after weaning from artificial ventilation.
During acute respiratory distress syndrome (ARDS), lung damage, coupled with positive pressure artificial ventilation, can lead to failure of the right ventricle by modifying its loading conditions. The "protective" modalities used today to ventilate these patients have reduced the incidence of this right heart failure in ARDS. However, the evolution of right heart failure during mechanical ventilation, and its consequence on the hemodynamic state of the patient are poorly determined. The aim of this study is to improve knowledge in this area.The main objective of the current project is to describe the incidence of right heart failure in patients with ARDS placed on artificial ventilation and its evolution over time. The secondary objectives are to describe the simultaneous evolution of the hemodynamic state, the use of cardiovascular drugs and the variables of tissue oxygenation, to describe the phenotypes of patients presenting with right heart failure during ARDS in function of ultrasound, hemodynamic and tissue oxygenation characteristics, to describe the association of these different phenotypes with the prognosis, to describe the risk factors for these different phenotypes and to describe the influence on right heart failure during ARDS on factors related to the patient's volume status.
In adult patients hospitalized in intensive care presenting with ARDS, the investigators will collect data recorded during the first 24 hours, after 48-96 hours, on day 5-7 and within 48 hours after extubation. The investigators will collect ventilatory and hemodynamic data, data provided by cardiac ultrasound, vasopressor and inotropic drug doses and tissue oxygenation variables.
This is an observational multicenter study, in which the investigators plan to include 500 patients over a total period of 24 months.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.
* Age ≥18 years old * Hospitalization in intensive care * Presence of ARDS according to the current consensus definition
Incidence and evolution of right heart failure during ARDS
Interpretation of echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day and after extubation.
Time frame: From enrollment to the end of the treatment at 8 weeks
The temporal evolution of the haemodynamic status
Describe the temporal evolution of hemodynamic status, assessed by changes in cardiovascular medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %) on the same days as the echocardiography.
Time frame: From enrollment to the end of treatment at 8 weeks
Phenotypic description of patients affected by right heart failure during ARDS
Identification and description of different phenotypes of RV failure in ARDS based on data from ultrasound, haemodynamic and tissue oxygenation characteristics the same day of echocardiography
Time frame: From enrollment to the end of treatment at 8 weeks
Association of these different phenotypes with the prognosis
Time frame: From enrollment to the end of the treatment at 8 weeks
Describe the risk factors for the occurrence of different phenotypes of right heart failure during ARDS
To describe the risk factors for the ocurrence of different phenotypes of right heart failure during ARDS, based on hemodynamic status including systemic and pulmonary arterial pressure (mmHg), medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %), as well as echocardiographic assessment.
Time frame: From enrollment to the end of treatment at 8 weeks
Effects of right ventricular failure on tests and indices of preload dependence using mechanical ventilation
Tests of preload dependence used in clinical praxis and ultrasound characteristics the same day of echocardiography
Time frame: From enrollment to the end of treatment at 8 weeks
Describe the effect of norepinephrine and/or vasopressin on the pulmonary circulation
In patients with treatment of norepinephrine or vasopressin the effect on the pulmonary circulation will be studied with hemodynamic monitoring such as echocardiography and pulmonary artery catheter according to clinical care.
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Jan 2028, 61 months after the start.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 61 months is above that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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