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NCT Number: NCT07450846

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Cardiovascular Diseases Heart Diseases Heart Failure Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Right Heart Failure Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The temporal evolution of the haemodynamic status

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  2. Phenotypic description of patients affected by right heart failure during ARDS

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  3. Association of these different phenotypes with the prognosis

    Time frame: From enrollment to the end of the treatment at 8 weeks

  4. 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

    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.

  5. 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

    Tests of preload dependence used in clinical praxis and ultrasound characteristics the same day of echocardiography

  6. Describe the effect of norepinephrine and/or vasopressin on the pulmonary circulation

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Lai, MD, PhD

CONTACT

[email protected]

+33145212671

Xavier Monnet, MD, PhD

CONTACT

[email protected]

+33-(0)6660862669

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Collaborators

  • Henri Mondor University Hospital
  • Humanitas Hospital, Italy
  • Hôpital Cochin
  • Tenon Hospital, Paris

Registry information

Official study title

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study

Acronym: IVOLIA

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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