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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | In ICU mortality | up to 12 weeks |
| hospital mortality | In hospital mortality | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 28 days without mechanical ventilation | 28 days without mechanical ventilation | up to 28 days |
| length of stay in the ICU | length of stay in the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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Updated global diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) in 2023 are as follows:
Supportive respiratory criteria: Endotracheal intubation, or non-invasive ventilation (NIV)/continuous positive airway pressure (CPAP) with minimum expiratory positive airway pressure (EPAP) ≥ 5 cmH2O, or high-flow nasal oxygen therapy with a minimum flow rate ≥ 30 L/min.
Hypoxemia criteria: Arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) ≤ 300 mmHg, or peripheral oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) ≤ 315 mmHg, with simultaneous peripheral oxygen saturation (SpO2) ≤ 97%.
Radiographic criteria: Chest X-ray, chest computed tomography (CT), or trained ultrasound confirming bilateral pulmonary opacities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingen Xia, M.D | Contact | +8613466396561 | 13466396561@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jingen Xia | China-Japan Friendship Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jingen Xia | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28792873 | Background | Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available. | |
| 32819400 | Background | Huang X, Zhang R, Fan G, Wu D, Lu H, Wang D, Deng W, Sun T, Xing L, Liu S, Wang S, Cai Y, Tian Y, Zhang Y, Xia J, Zhan Q; CHARDSnet group. Incidence and outcomes of acute respiratory distress syndrome in intensive care units of mainland China: a multicentre prospective longitudinal study. Crit Care. 2020 Aug 20;24(1):515. doi: 10.1186/s13054-020-03112-0. |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D001992 | Bronchoalveolar Lavage Fluid |
| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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We plan to collect peripheral blood and bronchoalveolar lavage fluid.
| up to 12 weeks |
| Total length of hospital stay | Total length of hospital stay | up to 24 weeks |
| Mortality at 1 year after discharge | Mortality at 1 year after discharge | through study completion, an average of 1 year |
| 31060085 | Background | Reilly JP, Calfee CS, Christie JD. Acute Respiratory Distress Syndrome Phenotypes. Semin Respir Crit Care Med. 2019 Feb;40(1):19-30. doi: 10.1055/s-0039-1684049. Epub 2019 May 6. |
| 34652268 | Background | Shah FA, Meyer NJ, Angus DC, Awdish R, Azoulay E, Calfee CS, Clermont G, Gordon AC, Kwizera A, Leligdowicz A, Marshall JC, Mikacenic C, Sinha P, Venkatesh B, Wong HR, Zampieri FG, Yende S. A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021 Oct 15;204(8):891-901. doi: 10.1164/rccm.202108-1908ST. |
| 24853585 | Background | Calfee CS, Delucchi K, Parsons PE, Thompson BT, Ware LB, Matthay MA; NHLBI ARDS Network. Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials. Lancet Respir Med. 2014 Aug;2(8):611-20. doi: 10.1016/S2213-2600(14)70097-9. Epub 2014 May 19. |