Early Biological and Mechanical Profiling in Sepsis-Associated ARDS

NCT07281911 | Not Yet Recruiting

• 1 other identifier: EARLY-SARDS-2025-11
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

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.

  From enrollment to 72 hours

Study Arms (1)

ARDS secondary to sepsis, requiring intubation and mechanical ventilation

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥18
• ARDS diagnosis per Berlin definition
• Sepsis per Sepsis-3 criteria
• Invasive mechanical ventilation
• Expected to remain intubated ≥72 hours
• Consent from surrogate

You may not qualify if:

• Contraindications to bronchoscopy/BAL
• Refractory hemodynamic instability
• Pregnancy
• Pulmonary transplant patients
• Surrogate declines participation

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Sepsis; Acute Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases

Study Officials

• Maria Martínez Pla, MD

  SODIR (Shock, Disfunció Orgànica i Ressuscitació)

  PRINCIPAL INVESTIGATOR

• Luis Chiscano Camon, MD, PhD

  SODIR (Shock, Disfunció Orgànica i Ressuscitació)

  STUDY DIRECTOR

• Luis Morales Quinteros, MD, PhD

  SODIR (Shock, Disfunció Orgànica i Ressuscitació)

  STUDY CHAIR

Central Study Contacts

Maria Martínez Pla, MD

CONTACT

+34636602073; maria.martinezpla@vallhebron.cat

Luis Chiscano Camon, MD, PhD

CONTACT

+34 659584804; luissilvestre.chiscano@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)