ALI/ARDS Clinical Sub-phenotyping Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-14

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Realworld Study of Acute Respiratory Distress Syndrome in China

NCT02975908

Acute Respiratory Distress Syndrome

UNKNOWN

Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

NCT06069466

Acute Respiratory Distress Syndrome

UNKNOWN

Acute CorPulmonale and ARDS Circulation Protection China Study China (ACPC)

NCT03827863

ARDS (Acute Respiratory Distress Syndrome) Acute Cor Pulmonale

UNKNOWN

Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome

NCT04009330

Acute Respiratory Distress Syndrome (ARDS)

ACTIVE_NOT_RECRUITING

Exploration of Diagnosis and Treatment Strategies and Prognostic Prediction Models for Acute Respiratory Distress Syndrome Based on Radiographic Evaluations Assessed by Artificial Intelligence

NCT07328997

ARDS (Acute Respiratory Distress Syndrome) AI (Artificial Intelligence)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collect peripheral blood and bronchoalveolar lavage fluid

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.