Actively Recruiting

Age: 18Years +
All Genders
ID06123962

Acute Lung / Acute Respiratory Distress Syndrome and Extra-pulmonary Organ Injury Clinical Sub-phenotyping Study

Led by China-Japan Friendship Hospital · Updated on 2025-02-12

1500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating acute lung injury and acute respiratory distress syndrome (ARDS), serious critical illnesses with high mortality rates of 45% to 50%. The study aims to understand the differences among patients with these conditions by creating a clinical classification system for lung and other organ injuries. This work hopes to enable personalized treatments and improve patient outcomes by analyzing clinical, physiological, and biological data. The study will collect clinical information and biological samples nationwide from patients diagnosed with ARDS. Peripheral blood samples will be taken at five specific times after ICU admission, and bronchoalveolar lavage fluid will be collected within 24 hours of ICU admission if the patient meets ARDS criteria. Mathematical and machine learning models will be used to develop and validate classification systems, including a bedside decision tool to guide precise diagnosis and treatment. Participants will contribute data and samples while in the ICU, with follow-up monitoring of outcomes such as ICU mortality (up to 12 weeks), hospital mortality (up to 24 weeks), time without mechanical ventilation (28 days), ICU and hospital length of stay, and mortality one year after discharge. The study seeks to build a comprehensive database and biobank to support future research and improve care for ARDS patients.

CONDITIONS

Brief Title

ALI/ARDS Clinical Sub-phenotyping Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) according to the updated global definition in 2023
  • The patient or their legal representative signs an informed consent form
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 years old
  • Those who refuse to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to ICU discharge or death, within approximately 3 to 4 days

Participants will have peripheral blood and bronchoalveolar lavage fluid collected to analyze acute lung injury and organ injury sub-phenotypes.

5 collection time points: Day 0, Day 1, Day 2, Day 3 after ICU admission, and day of ICU discharge or death; plus 1 bronchoalveolar lavage fluid collection within 24 hours after ICU admission

Long-term Monitoring

Duration - Up to 1 year after discharge

Participants are observed over time to assess mortality, mechanical ventilation duration, and length of hospital and ICU stay.

Follow-up assessments up to 1 year post-discharge

Trial Site Locations

Total: 1 location

1

Jingen Xia

Beijing, China

Actively Recruiting

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Research Team

J

Jingen Xia, M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Incidence and outcomes of acute respiratory distress syndrome in intensive care units of mainland China: a multicentre prospective longitudinal study.

Xu Huang, Ruoyang Zhang, Guohui Fan...

https://pubmed.ncbi.nlm.nih.gov/32819400

A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement.

Faraaz Ali Shah, Nuala J Meyer, Derek C Angus...

https://pubmed.ncbi.nlm.nih.gov/34652268

Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials.

Carolyn S Calfee, Kevin Delucchi, Polly E Parsons...

https://pubmed.ncbi.nlm.nih.gov/24853585