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

NCT07450846 | Recruiting

• 1 other identifier: 22-068
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Distress Syndrome; Right Heart Failure

Keywords

ARDS; heart-lung interactions; mechanical ventilation; shock

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of the treatment at 8 weeks

Secondary Outcomes (6)

• The temporal evolution of the haemodynamic status

  From enrollment to the end of treatment at 8 weeks

• Phenotypic description of patients affected by right heart failure during ARDS

  From enrollment to the end of treatment at 8 weeks

• Association of these different phenotypes with the prognosis

  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

  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

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Patients with ARDS under mechanical ventilation

* Age ≥18 years old * Hospitalization in intensive care * Presence of ARDS according to the current consensus definition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Hospitalization in intensive care * Age ≥18 years * Patients under mechanical ventilation * Presence of acute respiratory distress syndrome according to the Berlin definition

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bicetre Hospital: lead
• Tenon Hospital, Paris: collaborator
• Hôpital Cochin: collaborator
• Henri Mondor University Hospital: collaborator
• Humanitas Hospital, Italy: collaborator

Study Sites (1)

Chu de Bicêtre, AP-HP

Le Kremlin-Bicêtre, 94270, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Heart Failure; Shock

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xavier Monnet, MD, PhD

CONTACT

+33-(0)6660862669; xavier.monnet@aphp.fr

Christopher Lai, MD, PhD

CONTACT

+33145212671; christopher.lai@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: March 5, 2026
• Study Start: December 22, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)