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NCT07281911

Early Biological and Mechanical Profiling in Sepsis-Associated ARDS

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Characterization of Early Biological and Mechanical Profiles in Sepsis-Associated ARDS for Studying Compartamentalization (Serial Bronchoalveolar Lavage and Plasma Biomarkers) to Identify Inflammatory and Hybrid Subphenotypes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-03-01

Completion Date

2027-11-01

Last Updated

2025-12-15

Healthy Volunteers

No

Locations (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain