Acute Respiratory Distress SyndromeIVOLIANCT07450846
Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome and Right Heart Failure, run by Bicetre Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Right Heart Failure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2022to Jan 2028
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Hospitalization in intensive care * Age ≥18 years * Patients under mechanical ventilation * Presence of acute respiratory distress syndrome according to the Berlin definition
Who may be able to join
- Age ≥18 years old
- Hospitalization in intensive care undergoing mechanical ventilation
- Presence of ARDS according to the current consensus definition (Berlin definition)
- Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation
Who cannot join
- Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu de Bicêtre, AP-HP
Le Kremlin-Bicêtre, 94270
Xavier Monnet, MD, PhD, +33680821557, xavier.monnet@aphp.fr
Christopher Lai, MD, PhD, 0145212671, christopher.lai@aphp.fr
About this study
Official title: Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
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.
Read the detailed description
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.
- Keywords
- ARDS, heart-lung interactions, mechanical ventilation, shock
- Medical subject headings
- Respiratory Distress Syndrome, Heart Failure, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ARDS under mechanical ventilation | * Age ≥18 years old * Hospitalization in intensive care * Presence of ARDS according to the current consensus definition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the treatment at 8 weeks
Secondary outcomes (6)
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.
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks
Association of these different phenotypes with the prognosis
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start22 Dec 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tenon Hospital, Paris, Hôpital Cochin, Henri Mondor University Hospital, Humanitas Hospital, Italy
- Responsible party
- Principal investigator, Xavier Monnet, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450846
- Sponsor's protocol ID
- 22-068
- Acronym
- IVOLIA
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
- ClinicalTrials.gov ID
- NCT07450846
- Acronym / sponsor ID
- IVOLIA / 22-068
- Keywords
- ARDS, heart-lung interactions, mechanical ventilation, shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Collaborators
- Tenon Hospital, Paris, Hôpital Cochin, Henri Mondor University Hospital, Humanitas Hospital, Italy
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Mar 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ARDS under mechanical ventilation | – | –* Age ≥18 years old * Hospitalization in intensive care * Presence of ARDS according to the current consensus definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Hospitalization in intensive care * Age ≥18 years * Patients under mechanical ventilation * Presence of acute respiratory distress syndrome according to the Berlin definition
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Hospitalization in intensive care undergoing mechanical ventilation
- Presence of ARDS according to the current consensus definition (Berlin definition)
- Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation
Key exclusion criteria (1 listed)
- Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.
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 and evolution of right heart failure during ARDS
Time frame: From enrollment to the end of the treatment at 8 weeks
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.
6 secondary outcomes
The temporal evolution of the haemodynamic status
Time frame: From enrollment to the end of treatment at 8 weeks
Phenotypic description of patients affected by right heart failure during ARDS
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
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
Time frame: From enrollment to the end of treatment at 8 weeks
Describe the effect of norepinephrine and/or vasopressin on the pulmonary circulation
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Acute Respiratory Distress Syndrome and Right Heart Failure, run by Bicetre Hospital at 1 site 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Monnet, MD, PhD (+33-(0)6660862669, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and evolution of right heart failure during ARDS (time frame: From enrollment to the end of the treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.