Clinical trial NCT06123962: ALI/ARDS Clinical Sub-phenotyping Study
Official title: Acute Lung/ Acute Respiratory Distress Syndrome and Extra-pulmonary Organ Injury Clinical Sub-phenotyping Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Keywords: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Sub-phenotypes
Treatment strategies
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU mortality
timeFrame: up to 12 weeks
measure: hospital mortality
timeFrame: up to 24 weeks
Secondary outcomes:
measure: 28 days without mechanical ventilation
timeFrame: up to 28 days
measure: length of stay in the ICU
timeFrame: up to 12 weeks
measure: Total length of hospital stay
timeFrame: up to 24 weeks
measure: Mortality at 1 year after discharge
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jingen Xia
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jingen Xia
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.