Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSoutheast University, China

About this trial

Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-"hyperinflammatory" and "hypoinflammatory"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

ARDS with new Global definition.

Onset of ARDS within 72 hours.

Disqualifiers

Refusal of informed consent by the patient's legally authorized representative.

Patients expected to die within 24 hours

Receiving extracorporeal membrane oxygenation at the time of recruitment

Trial population

Patients with ARDS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ARDS Inflammatory Subphenotypes

    Other intervention

    ARDS patients with idfferent Inflammatory Subphenotypes

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: ARDS patients with hyperinflammatory phenotype1 intervention

Trial outcomes

Primary outcomes

1

28-day mortality

The proportion of patients who are died within 28 days

Time frame
From inclusion to 28 days

Secondary outcomes

1

60-day mortality

The proportion of patients who are died within 60 days

Time frame
From inclusion to 60 days
2

Ventilator-free days at 28 days

Days alive without endotracheal intubation and invasive mechanical ventilation

Time frame
From inclusion to 28 days
3

Vasopressor-free days at 28 days

Days alive without use of vasopressor

Time frame
From inclusion to 28 days

Other outcomes

Sponsors and contacts

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