Early Biological and Mechanical Profiling in Sepsis-Associated ARDS

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 1 trial group
Group A: ARDS secondary to sepsis, requiring intubation and mechanical ventilation

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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