Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)NCT06123962
ALI/ARDS Clinical Sub-phenotyping Study
An observational study of Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Collect peripheral blood and bronchoalveolar lavage fluid
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals aged less than 18 years old.
- Those who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Lung/ Acute Respiratory Distress Syndrome and Extra-pulmonary Organ Injury Clinical Sub-phenotyping Study
- Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome.
- 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.
Read the 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.
- Being tested
- Collect peripheral blood and bronchoalveolar lavage fluid
- Keywords
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Sub-phenotypes, Treatment strategies
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect peripheral blood and bronchoalveolar lavage fluidProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
In ICU mortality
Measured: up to 12 weeks
hospital mortality
In hospital mortality
Measured: up to 24 weeks
Secondary outcomes (4)
28 days without mechanical ventilation
28 days without mechanical ventilation
Measured: up to 28 days
length of stay in the ICU
length of stay in the ICU
Measured: up to 12 weeks
Total length of hospital stay
Total length of hospital stay
Measured: up to 24 weeks
Mortality at 1 year after discharge
Mortality at 1 year after discharge
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start14 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingen Xia, China-Japan Friendship Hospital
- Investigators
- Jingen Xia, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123962
- Sponsor's protocol ID
- 2022YFC2504401
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28792873Huang 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.
PubMed 32819400Reilly 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.
PubMed 31060085Shah 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.
PubMed 34652268Calfee 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.
PubMed 24853585
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lung/ Acute Respiratory Distress Syndrome and Extra-pulmonary Organ Injury Clinical Sub-phenotyping Study
- ClinicalTrials.gov ID
- NCT06123962
- Acronym / sponsor ID
- 2022YFC2504401
- Keywords
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Sub-phenotypes, Treatment strategies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals aged less than 18 years old.
- Those who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect peripheral blood and bronchoalveolar lavage fluidPeripheral 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. | Procedure or surgery | – |
Primary outcome
ICU mortality
Time frame: up to 12 weeks
In ICU mortality
hospital mortality
Time frame: up to 24 weeks
In hospital mortality
4 secondary outcomes
28 days without mechanical ventilation
Time frame: up to 28 days
length of stay in the ICU
Time frame: up to 12 weeks
Total length of hospital stay
Time frame: up to 24 weeks
Mortality at 1 year after discharge
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 28792873Thompson 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.
- Background: PubMed 32819400Huang 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.
- Background: PubMed 31060085Reilly 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.
- Background: PubMed 34652268Shah 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.
- Background: PubMed 24853585Calfee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingen Xia study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingen Xia, M.D (+8613466396561, 13466396561@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123962, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.