About this trial
Sepsis-associated acute respiratory distress syndrome (ARDS) is one of the deadliest and most biologically heterogeneous forms of respiratory failure. Despite uniform diagnostic criteria, patients with septic ARDS show wide variability in inflammatory intensity, alveolar epithelial and endothelial injury, alveolar fluid composition, ventilatory mechanical properties, and clinical evolution. Early identification of these differences may enable better prognostication and more precise treatment.
This prospective observational study aims to deeply characterize the earliest phases of septic ARDS by integrating serial bronchoalveolar lavage (BAL) at 0, 24 and 72 hours with parallel plasma biomarker profiling and detailed mechanical ventilation data. This design captures the evolving biological and physiological landscape of septic ARDS during its most dynamic window. The central goal is to identify systemic, alveolar, and hybrid bio-mechano-inflammatory subphenotypes that can inform personalized approaches to support, risk stratification, and future interventional trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
ARDS diagnosis per Berlin definition
Sepsis per Sepsis-3 criteria
Invasive mechanical ventilation
Disqualifiers
Contraindications to bronchoscopy/BAL
Refractory hemodynamic instability
Pregnancy
Pulmonary transplant patients
Trial population
Participants are adult ICU patients diagnosed with ARDS secondary to sepsis, requiring intubation and mechanical ventilation. Because the great majority will be sedated or unconscious, informed consent will be sought from legally authorized representatives. This population is particularly prone to adverse outcomes, making biological and mechanical profiling both valuable and clinically meaningful.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Early hybrid biological-mechanical subphenotypes
Identification of early alveolar inflammatory subphenotypes, defined by trajectories of BAL biomarkers (IL-6, IL-8, IL-10, TNF-α, sRAGE, KL-6, SP-D, Ang-2, vWF, total protein, albumin) and Mechanical Profiles in Sepsis-Associated ARDS.
Sponsors and contacts
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