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NCT Number: NCT06123962

ALI/ARDS Clinical Sub-phenotyping Study

1. Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome. 2. By deciphering the heterogeneity of patients with acute lung injury/ acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.

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Key information

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jingen Xia

Beijing, China

Location status: Recruiting

Location contact

Jingen Xia, MD

CONTACT

About this study

Acute lung injury/ acute respiratory distress syndrome is one of the most common and complex critical illnesses in clinical practice, with a high mortality rate of 45% to 50%. Currently, effective therapeutic strategies for this condition are still lacking. Increasing evidence suggests that the significant heterogeneity of this disease plays a crucial role in the poor treatment outcomes and high mortality rates observed in patients. Therefore, this study aims to analyze the heterogeneity of acute lung injury/ acute respiratory distress syndrome patients and establish a clinical classification system for acute lung and extrapulmonary organ injuries.

The objectives of this study include establishing a nationwide clinical database and biobank for acute lung injury / acute respiratory distress syndrome by collecting clinical data and biological samples from various provinces. By overcoming the barriers posed by diverse and heterogeneous data sources, mathematical and machine learning models will be utilized to construct clinical, physiological, and biological classification systems for acute lung and extrapulmonary organ injuries. The proposed classification model will be validated multiple times using international public databases and prospective acute lung injury/acute respiratory distress syndrome cohorts to ensure its stability and generalizability. The mapping relationship between different classifications and patient prognosis as well as treatment responsiveness will be explored.

Moreover, a machine learning-based supervised technique will be applied to develop a bedside simplified model (Point-of-Care model) and establish a bedside clinical classification decision system. Ultimately, this research aims to provide a foundation for standardized and precision-guided clinical diagnostic and therapeutic pathways, promoting improved treatment outcomes and overall prognosis in acute lung injury/ acute respiratory distress syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals aged less than 18 years old.
  • Those who refuse to participate in the study.

Treatment and study plan

Collect peripheral blood and bronchoalveolar lavage fluid

Procedure

Peripheral venous blood will be collected and stored from the study participants at a total of five time points: Day 0, Day 1, Day 2, Day 3 after admission to the ICU, and the day of ICU discharge/death. The collection will be conducted after assessing the patients' eligibility for ARDS diagnosis. Each time point will involve the collection of one tube of peripheral venous blood, totaling 5 mL per sample.

Within 24 hours after patients' admission to the ICU and meeting the assessment criteria for ARDS diagnosis, bronchoalveolar lavage fluid (BALF) will be collected and retained, totaling 10 mL.

Primary outcomes

  1. ICU mortality

    Time frame: up to 12 weeks

    In ICU mortality

  2. hospital mortality

    Time frame: up to 24 weeks

    In hospital mortality

Secondary outcomes

  1. 28 days without mechanical ventilation

    Time frame: up to 28 days

    28 days without mechanical ventilation

  2. length of stay in the ICU

    Time frame: up to 12 weeks

    length of stay in the ICU

  3. Total length of hospital stay

    Time frame: up to 24 weeks

    Total length of hospital stay

  4. Mortality at 1 year after discharge

    Time frame: through study completion, an average of 1 year

    Mortality at 1 year after discharge

Study contacts

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

Jingen Xia, M.D

CONTACT

[email protected]

+8613466396561

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2023
Registry last updated
Feb 12, 2025

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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