Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
Recruiting now
Conditions studied: Acute Respiratory Distress Syndrome (ARDS)
In brief
About 10% of patients admitted to the ICU suffer from ARDS, with a mortality rate of around 35-45%. The lack of therapeutic innovation in ARDS can be partly explained by the heterogeneity of patients included under this definition. A better understanding of the pathophysiological mechanisms underlying the different patient phenotypes is essential to develop new therapeutic strategies. Objectives: To characterize the inflammatory profile of patients with ARDS using circulating biomarkers and single-cell RNA sequencing of pulmonary immune cells. The investigators hypothesize that there is a correlation between the profile of serum biomarkers (inflammatory sub-phenotypes), the transcriptome of pulmonary immune cells. Briefly the experimental scheme is as follow: * Population: patients with ARDS under invasive mechanical ventilation in the ICU. * Intervention: 1. Determination of the inflammatory subphenotype on circulatory inflammatory biomarkers. 2. Characterization of inflammation by single cell RNA sequencing on lung immune cells collected on broncho-alveolar fluid.
Key facts
- Study ID
- NCT07395076
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 50
- Starts
- 2026-05-11
- Expected to finish
- 2029-05-11
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ARDS risk factors: bacterial or viral pneumonia, extrapulmonary infection, major trauma, transfusion, inhalation injury, or shock.
- Pulmonary edema not explained by a cardiogenic cause or volume overload.
- Onset of respiratory symptoms within <7 days.
- Bilateral pulmonary involvement on chest X-ray, CT scan, or ultrasound.
- PaO₂/FiO₂ ≤ 300 assessed with PEEP ≥ 5 cmH₂O.
You may not qualify if…
- ARDS with intubation for more than 48 hours.
- Contraindications to bronchoscopy: effective anticoagulation, dual antiplatelet therapy, thrombocytopenia <50 G/L.
- Pre-existing immunodeficiency: active solid tumor or remission <5 years, active hematologic malignancy or remission <5 years, systemic disease (even without specific treatment), solid organ or bone marrow transplant, HIV infection with CD4 <200/mm³.
- Cardiac arrest with a poor prognosis (NSE >60, malignant EEG, diffuse ischemia on imaging, loss of trunk reflexes).
- Patients <18 year-old
- Patients under legal guardianship, curatorship, or deprived of liberty.
- Ongoing pregnancy.
- Patients without social security coverage.
Where it is running
- Hôpital Lariboisière — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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