An observational study in Acute Hypoxemic Respiratory Failure, Sepsis and ARDS (Acute Respiratory Distress Syndrome), sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
Among 69 studies in Respiratory Insufficiency with a site in Spain — 11 open to participants now, 15 under way, none of them phase 3. Respiratory Insufficiency · Spain.
Among the 69 studies in Respiratory Insufficiency with a site in Spain, this one is the 22nd largest by planned enrollment of the 31 observational ones, is one of 5 that started in 2026, is one of 31 observational ones, reaches primary completion later than 13 of the 14 other live ones, and was the 64th registered.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 145 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →11 of the 69 studies in Respiratory Insufficiency with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 178 Respiratory Insufficiency studies recruiting now, 134 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →69 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 5 started in 2026.
Median enrollment 116 across the 38 interventional studies, 298 across the 31 observational. Of the 42 that completed or were terminated, 6 (14%) have results posted.
10 of 69 have an industry lead sponsor. The 10 most frequent:
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Hospital Universitari Vall d'Hebron Research Institute has 6 studies filed under Respiratory Insufficiency — fewer than ten, so there is no comparison to draw.
7 of the studies in Respiratory Insufficiency with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07679646Air Liquide Healthcare SpainEffectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO) | 2026-12 |
| NCT07098611Medipol UniversityA New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score | 2026-12-30 |
| NCT07178483Hospital Universitari de BellvitgeEvaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure | 2027-03-01 |
| NCT05440851University Health Network, TorontoPlatform of Randomized Adaptive Clinical Trials in Critical Illness | 2027-03-31 |
| NCT07708506Jesus VillarIs Hypoxemia Driving Outcome in Acute Hypoxemic Respiratory Failure? (HOMELAND Study) | 2027-07-29 |
Among the 69 studies in Respiratory Insufficiency with a site in Spain, from their registry updates:
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.
Acute respiratory distress syndrome (ARDS) secondary to sepsis is a biologically heterogeneous syndrome that reflects multiple interacting mechanisms of lung injury rather than a single pathological process. Current clinical definitions rely on physiological manifestations of established lung injury and therefore provide limited insight into the underlying biological processes responsible for disease initiation and progression.
Experimental and translational studies indicate that the earliest phase of sepsis-associated lung injury is characterized by dynamic interactions between inflammatory activation, epithelial injury, endothelial dysfunction, disruption of the alveolar-capillary barrier, and alterations in pulmonary permeability. These processes evolve rapidly during the first days after sepsis onset and may precede the clinical diagnosis of ARDS by several hours or days. Longitudinal characterization is therefore essential to understand the temporal evolution of lung injury.
Because the primary site of injury is the alveolar compartment, circulating biomarkers incompletely reflect the biological events occurring within the lung. Inflammatory mediators, epithelial injury markers, and endothelial activation frequently demonstrate compartmentalization between bronchoalveolar lavage (BAL) fluid and plasma, suggesting that simultaneous assessment of both compartments may provide a more comprehensive characterization of early lung injury than either compartment alone.
Respiratory physiology represents a complementary dimension of ARDS pathophysiology. Parameters including respiratory system compliance, driving pressure, plateau pressure, ventilatory ratio, and gas exchange describe the functional consequences of biological injury and the mechanical environment to which the lung is exposed during invasive mechanical ventilation. Mechanical stress and biological injury are closely interconnected and likely contribute jointly to disease progression.
By combining repeated assessment of alveolar biology, systemic host response, and respiratory physiology during the earliest phase of sepsis-associated respiratory failure, this study is designed to characterize the temporal evolution of lung injury and provide an integrated description of the biological and physiological mechanisms underlying progression to ARDS.
Participants are adult ICU patients admitted with sepsis or septic shock who require invasive mechanical ventilation within 72 hours of sepsis diagnosis. These patients represent a high-risk population for sepsis-associated lung injury and ARDS, with dynamic biological and physiological changes occurring during the earliest phase of critical illness. The study follows participants for the first 96 hours after sepsis diagnosis to capture these early trajectories.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Serial bronchoalveolar lavage and biological-physiological assessment
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.
Early lung injury trajectory within 96 hours of sepsis onset
Early lung injury trajectory, assessed as an ordinal composite endpoint integrating: 1. occurrence of ARDS according to the Berlin Definition, 2. time from sepsis diagnosis to ARDS onset, 3. the highest Berlin ARDS severity stage (mild, moderate, or severe) reached during the 96-hour observation period. This endpoint will serve as the outcome for development and internal validation of an integrated biological-physiological prediction model combining alveolar and systemic biomarkers with respiratory physiological variables.
Time frame: Baseline to 96 hours
Alveolar-systemic biological compartmentalization
Alveolar-to-plasma biomarker gradients, concordance between paired bronchoalveolar lavage (BAL) and plasma biomarkers, and identification of compartmentalized biological profiles associated with early lung injury.
Time frame: Baseline to 96 hours
Incremental predictive performance of integrated biological-physiological models
Improvement in model discrimination, calibration, reclassification, and clinical utility after incorporation of alveolar biomarkers and respiratory physiological variables into conventional clinical and plasma-based prediction models.
Time frame: Baseline to 96 hours
Reproducibility and external validation of biological-physiological models
Assessment of biomarker distributions, alveolar-systemic gradients, biological-physiological subphenotype assignment, and prediction model performance across the prospective multicentre derivation cohort, including Vall d'Hebron and Uppsala University, with external validation in an independent retrospective Amsterdam UMC cohort.
Time frame: Once study is completed, avarage 2 years
Plan to share: No — No plan to share IPD because of data sensitivity and institutional data protection requirements
Start is estimated for Oct 2026; primary completion for Mar 2028, 16 months later.
Of 232 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 16 months is below that.
Counting every sponsor, half of 248 studies reached it within 22 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute →