Immune mechanisms in acute respiratory distress syndrome in ventilated ICU patients.
Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
This project will test whether patterns of inflammatory markers in blood match gene activity of lung immune cells in adults with ARDS who are on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07395076 on ClinicalTrials.gov |
What this trial studies
The study enrolls adults with ARDS receiving invasive mechanical ventilation in the ICU and profiles circulating inflammatory biomarkers to define inflammatory subphenotypes. Investigators obtain pulmonary immune cells (likely via bronchoalveolar sampling) and perform single-cell RNA sequencing to capture cell-specific transcriptomes. They then correlate serum biomarker patterns with lung immune cell gene-expression profiles to identify distinct biological endotypes. The goal is to better understand pathophysiological mechanisms that underlie heterogeneous ARDS presentations and inform more targeted therapies.
Who should consider this trial
Good fit: Adults with ARDS of ≤7 days' onset who are on invasive mechanical ventilation with PaO2/FiO2 ≤300 (PEEP ≥5) and can safely undergo bronchoscopy are the intended participants.
Not a fit: Patients intubated for more than 48 hours, those with contraindications to bronchoscopy, pre-existing severe immunodeficiency, pregnancy, minors, or lacking required social coverage are unlikely to qualify or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could identify biological subgroups of ARDS patients and enable more personalized treatment approaches in future trials.
How similar studies have performed: Previous studies have identified plasma inflammatory subphenotypes in ARDS linked to different outcomes and treatment responses, but combining circulating biomarkers with single-cell lung transcriptomics is a relatively new approach with limited prior results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Patients \<18 year-old * Patients under legal guardianship, curatorship, or deprived of liberty. * Ongoing pregnancy. * Patients without social security coverage.
Where this trial is running
Paris
- Hôpital Lariboisière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Pierre-Louis BLOT, MD
- Email: pierre-louis.blot@aphp.fr
- Phone: +331049956565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.