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Early Biological and Mechanical Profiling in Sepsis-Associated ARDS

NCT07281911 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Acute Hypoxemic Respiratory Failure
  • Sepsis
  • ARDS (Acute Respiratory Distress Syndrome)

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Maria Martínez Pla, MD · SODIR (Shock, Disfunció Orgànica i Ressuscitació)

  • Luis Chiscano Camon, MD, PhD · SODIR (Shock, Disfunció Orgànica i Ressuscitació)

  • Luis Morales Quinteros, MD, PhD · SODIR (Shock, Disfunció Orgànica i Ressuscitació)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-09-01
Completion
2027-11-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281911 on ClinicalTrials.gov