Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Hospitalized patients in intensive care unit suffering from mechanically ventilated ARDS as defined by Matthay et al.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Single cell RNA sequencing of pulmonary immune cells
Single cell RNA sequencing of pulmonary immune cells collected during a bronchoalveolar lavage at inclusion.
Time frame
At baselineSecondary outcomes
1
Mortality
Mortality rate at day 90
Time frame
At day 902
Mortality
Mortality rate at one year
Time frame
1 year3
Time without respiratory support
Number of days alive without mechanical ventilation on day 28 after inclusion or on discharge from intensive care if this occurs before the 28th day
Time frame
At day 284
Length of stay in intensive care
Number of days in intensive care.
Time frame
From inclusion to ICU discharge up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov