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NCT Number: NCT07289711

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • ARDS with new Global definition.
  • Onset of ARDS within 72 hours.

Exclusion criteria

  • 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

Treatment and study plan

ARDS Inflammatory Subphenotypes

Other

ARDS patients with idfferent Inflammatory Subphenotypes

Primary outcomes

  1. 28-day mortality

    Time frame: From inclusion to 28 days

    The proportion of patients who are died within 28 days

Secondary outcomes

  1. 60-day mortality

    Time frame: From inclusion to 60 days

    The proportion of patients who are died within 60 days

  2. Ventilator-free days at 28 days

    Time frame: From inclusion to 28 days

    Days alive without endotracheal intubation and invasive mechanical ventilation

  3. Vasopressor-free days at 28 days

    Time frame: From inclusion to 28 days

    Days alive without use of vasopressor

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Chen, MD

CONTACT

[email protected]

+8618006138640

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Acronym: VATIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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