EARLY-SARDS: Early AlveolaR Lung biologY Underling Sepsis-Associated ARDS

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07281911
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serial bronchoalveolar lavage and biological-physiological assessment — DIAGNOSTIC_TEST
    At baseline (T0), blood samples and standardized respiratory physiological measurements, including gas exchange and ventilatory mechanics, will be obtained from all participants. Bronchoalveolar lavage (BAL) will be performed only in invasively mechanically ventilated patients meeting predefined safety criteria. T1 will occur 24 hours after T0 in patients already intubated or at the time of endotracheal intubation if this occurs within 72 hours of sepsis diagnosis. T2 will be performed 96 hours after sepsis diagnosis and at least 24 hours after the previous assessment. At each study point plasma sampling and physiological measurements will be repeated, while BAL will be repeated only when predefined safety criteria are fulfilled. All clinical management will remain at the discretion of the treating ICU team.

Study Details

Sepsis-associated acute respiratory distress syndrome (ARDS) remains a major cause of respiratory failure and mortality in critically ill patients. Although only a proportion of patients with sepsis develop ARDS, early identification of those at highest risk remains a major unmet clinical need. Current prediction relies largely on clinical deterioration and oxygenation impairment, which often occur when lung injury has already developed. Increasing evidence suggests that biological responses to sepsis are compartmentalized between the systemic circulation and the alveolar space, while early abnormalities in respiratory mechanics and ventilatory efficiency may provide complementary information on evolving lung injury. However, no prospective study has integrated serial systemic and alveolar biomarkers with bedside respiratory physiology during the earliest phase of sepsis-associated respiratory failure. EARLY-SARDS is a prospective observational cohort study designed to characterize the early biological and physiological trajectories of invasively ventilated patients with sepsis or septic shock. Serial bronchoalveolar lavage (BAL) and plasma samples, together with standardized measurements of respiratory mechanics and gas exchange, will be collected during the first 96 hours after enrollment. The primary objective is to develop an integrated biological-physiological model capable of predicting ARDS development and subsequent peak ARDS severity. Secondary objectives include characterizing biological compartmentalization, identifying integrated biological-physiological subphenotypes, and evaluating their association with clinically relevant outcomes, including duration of mechanical ventilation, ventilator-free days, need for extracorporeal respiratory support, ICU length of stay, and mortality.

Key Dates

First listed
Dec 15, 2025
Start date
Oct 15, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
145 participants (estimated)

Arms

  • Arm: Sepsis or Septic shock requiring mechanical ventilation
    Adult ICU patients with sepsis or septic shock requiring invasive mechanical ventilation within 72 hours from sepsis diagnosis will be consecutively enrolled and followed for 96 hours after sepsis diagnosis.

Primary Outcome Measure

Early lung injury trajectory within 96 hours of sepsis onset [ Time Frame: Baseline to 96 hours ]

Central Contacts

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