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

NCT07289711 | Recruiting DMC

• 1 other identifier: Subphenotype Of ARDS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  The proportion of patients who are died within 28 days

  From inclusion to 28 days

Secondary Outcomes (3)

• 60-day mortality

  From inclusion to 60 days

• Ventilator-free days at 28 days

  From inclusion to 28 days

• Vasopressor-free days at 28 days

  From inclusion to 28 days

Study Arms (1)

ARDS patients with hyperinflammatory phenotype

ARDS patients with hyperinflammatory phenotype

Other: ARDS Inflammatory Subphenotypes

Interventions

ARDS Inflammatory Subphenotypes OTHER

ARDS patients with idfferent Inflammatory Subphenotypes

ARDS patients with hyperinflammatory phenotype

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

Patients with ARDS

You may qualify if:

• Age ≥ 18 years.
• ARDS requiring invasive mechanical ventilation, diagnosed according to the 2023 Global definition.
• Onset of ARDS within 72 hours.

You may not qualify if:

• Refusal of informed consent by the patient's legally authorized representative.
• Patients expected to die within 24 hours

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Hui Chen, MD

CONTACT

+8618006138640; huichen.icu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)