Respiratory Distress Syndrome, AcuteNCT06973733
Multimodal Database and Large Language Model for ARDS
An observational study of Respiratory Distress Syndrome, Acute and Severe Community-Acquired Pneumonia, run by China-Japan Friendship Hospital.
Trial summary
The goal of this observational study is to integrate existing clinical cohorts from the research team to establish dedicated cohorts for ARDS and high-risk ARDS patients (primarily SCAP patients), then systematically collect comprehensive clinical data and multi-omics biological samples to construct a high-quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Acute, Severe Community-Acquired Pneumonia
- What is being tested?
- Clinical data and biospecimen collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6,500 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2025to 31 Mar 2028
- 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: 1. ARDS ptients; 2. ARDS high-risk patients
Who may be able to join
- 1. ARDS Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Meets the 2024 Global New Definition of ARDS (diagnosis confirmed by at least two experienced physicians; in case of disagreement, a third physician will adjudicate):Diagnostic Criteria:
- Risk Factors \& Origin of Pulmonary Edema:Acute risk factors (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, shock).
- Pulmonary edema not fully or primarily attributable to cardiogenic pulmonary edema/fluid overload.Hypoxemia/gas exchange abnormalities not primarily due to atelectasis.Exception: ARDS can still be diagnosed if predisposing risk factors exist, even with concurrent conditions.
- Timing:Acute onset or worsening of hypoxemic respiratory failure within 7 days of risk factor exposure or new/worsening respiratory symptoms.
- Chest Imaging (X-ray/CT/US):Bilateral opacities (not fully explained by effusions, atelectasis, or nodules/masses)；Ultrasound findings: Bilateral B-lines and/or consolidations.
- Oxygenation Status:
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- Non-intubated ARDS:PaO₂/FiO₂ ≤300 mmHg OR SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%). High-flow nasal oxygen (HFNO) ≥30 L/min or NIV/CPAP ≥5 cm H₂O.
- Intubated ARDS (all enrolled patients assessed via PaO₂/FiO₂):
- Mild: 200 < PaO₂/FiO₂ ≤300 OR 235 ≤ SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%). Moderate: 100 < PaO₂/FiO₂ ≤200 OR 148 < SpO₂/FiO₂ ≤235 (if SpO₂ ≤97%). Severe: PaO₂/FiO₂ ≤100 OR SpO₂/FiO₂ ≤148 (if SpO₂ ≤97%).
- Resource-limited settings:No PEEP/minimum oxygen flow required; SpO₂/FiO₂ ≤315 (if SpO₂ ≤97%).
- ( 4 ) Signed informed consent.
- 2. ARDS High-Risk Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Does not meet ARDS criteria at ICU admission but has high-risk factors for ARDS development, including: SCAP, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, aspiration.The primary etiology in this cohort is SCAP.
- SCAP Diagnostic Criteria (≥1 major or ≥3 minor criteria):
- Major Criteria:
- Requires mechanical ventilation (intubation).
- Septic shock requiring vasopressors after fluid resuscitation.
- Minor Criteria:
- Respiratory rate ≥30 breaths/min.
- PaO₂/FiO₂ ≤250 mmHg.
- Multilobar infiltrates.
- Altered mental status/disorientation.
- BUN ≥20 mg/dL (7.12 mmol/L).
- Leukopenia (WBC <4×10⁹/L).
- Thrombocytopenia (platelets <100×10⁹/L).
- Hypothermia (core temp <36°C).
- SBP <90 mmHg requiring aggressive fluid resuscitation.
- ( 4 ) Signed informed consent.
Who cannot join
- Patients without ARDS or ARDS high-risk factors.
- Age <18 years.
- Incomplete clinical data.
- Refusal to sign informed consent.
- Long-term nursing home residents.
- Tracheostomy patients.
- Currently enrolled in another clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction of ARDS Clinical Multimodal Database and ARDS-Specific Large Language Model
The goal of this observational study is to integrate existing clinical cohorts from the research team to establish dedicated cohorts for ARDS and high-risk ARDS patients (primarily SCAP patients), then systematically collect comprehensive clinical data and multi-omics biological samples to construct a high-quality multimodal ARDS database. Building upon this foundation, the research will develop an ARDS-specific large-scale disease model to assist clinical decision-making in early warning, diagnosis, and prognosis prediction. The main question it seeks to address is: Can the establishment of specialized ARDS cohorts and multimodal databases, combined with the development of an ARDS-specific large-scale disease model, effectively improve ARDS prediction rates, diagnostic accuracy, and reduce mortality rates, thereby enhancing overall clinical management standards?
Read the detailed description
ARDS is a common critical illness in ICUs with high mortality rates. Its prognostic factors are complex and multifaceted, including challenges in precise early warning, lack of early diagnostic biomarkers due to complicated pathogenesis, and difficulties in personalized precision treatment owing to high heterogeneity. Interventions targeting any single aspect are unlikely to improve overall outcomes. Only through systematic interventions addressing key aspects of ARDS - including assessment, early warning, diagnosis, phenotyping and treatment - can its mortality be significantly reduced.
This study is a multicenter, retrospective and prospective observational cohort study with the following objectives:
- To integrate existing ARDS-related cohorts from the research team (comprising 5,000 patients enrolled between January 1, 2014 and September 1, 2024) and prospectively recruit an additional 1,500 ARDS patients and ARDS high-risk individuals. This will establish a comprehensive cohort of no fewer than 6,500 cases, primarily including patient populations with conditions such as severe community-acquired pneumonia (SCAP) and other ARDS-associated disorders;
- To collect comprehensive clinical data and multi-omics biological samples from these patients, constructing a high-quality multimodal ARDS database through rigorous data governance;
- Based on this foundation, to develop and clinically validate an ARDS-specific large-scale disease model to assist in clinical decision-making for early warning, diagnosis, and prognosis prediction, thereby improving the overall standard of ARDS management.
- Being tested
- Clinical data and biospecimen collection
- Keywords
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data and biospecimen collectionBehavioural
Clinical Data Collection: Case report forms were utilized to systematically capture multimodal clinical data, including: demographic characteristics, clinical symptoms and physical signs, laboratory test results, chest imaging data, organ support parameters, pharmacological interventions , complications and clinical outcomes.
Biospecimen Collection: ARDS patients underwent biospecimen collection at days 1, 4, and 7 post-diagnosis. High-risk ARDS cohorts provided specimens within 24 hours of ICU admission. Specimens included: peripheral blood, Sputum/BALF, stool and urine.
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Patients meeting the 2024 global new definition of ARDS. Receives: Behavioral: Clinical data and biospecimen collection | |
| High-risk ARDS patients | Patients admitted to the ICU who do not meet ARDS diagnostic criteria but present with established ARDS risk factors, including: SCAP,, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, and aspiration.The primary etiology in this cohort is SCAP. Receives: Behavioral: Clinical data and biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the time frame would be 20 days.)
Hospital mortality
Measured: From the time of patient enrollment until hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)
Secondary outcomes (5)
ICU length of stay
Measured: From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the observation time frame would be 20 days.)
Hospital length of stay
Measured: From enrollment to hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)
Mortality rates at 28 days post-enrollment
Measured: From patient enrollment until 28 days post-enrollment
Mortality rates at 60 days post-enrollment
Measured: From patient enrollment until 60 days post-enrollment
Mortality rates at 90 days post-enrollment
Measured: From patient enrollment until 90 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start7 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AcuteStudies 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
- Other
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingyuan Zhan, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973733
- Sponsor's protocol ID
- 2024ZD0522702
- Status last verified
- May 2025
- First submitted
- 1 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of ARDS Clinical Multimodal Database and ARDS-Specific Large Language Model
- ClinicalTrials.gov ID
- NCT06973733
- Acronym / sponsor ID
- 2024ZD0522702
- Keywords
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 7 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 May 2025 (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.
The goal of this observational study is to integrate existing clinical cohorts from the research team to establish dedicated cohorts for ARDS and high-risk ARDS patients (primarily SCAP patients), then systematically collect comprehensive clinical data and multi-omics biological samples to construct a high-quality multimodal ARDS database. Building upon this foundation, the research will develop an ARDS-specific large-scale disease model to assist clinical decision-making in early warning, diagnosis, and prognosis prediction. The main question it seeks to address is: Can the establishment of specialized ARDS cohorts and multimodal databases, combined with the development of an ARDS-specific large-scale disease model, effectively improve ARDS prediction rates, diagnostic accuracy, and reduce mortality rates, thereby enhancing overall clinical management standards?
Detailed description
ARDS is a common critical illness in ICUs with high mortality rates. Its prognostic factors are complex and multifaceted, including challenges in precise early warning, lack of early diagnostic biomarkers due to complicated pathogenesis, and difficulties in personalized precision treatment owing to high heterogeneity. Interventions targeting any single aspect are unlikely to improve overall outcomes. Only through systematic interventions addressing key aspects of ARDS - including assessment, early warning, diagnosis, phenotyping and treatment - can its mortality be significantly reduced.
This study is a multicenter, retrospective and prospective observational cohort study with the following objectives:
- To integrate existing ARDS-related cohorts from the research team (comprising 5,000 patients enrolled between January 1, 2014 and September 1, 2024) and prospectively recruit an additional 1,500 ARDS patients and ARDS high-risk individuals. This will establish a comprehensive cohort of no fewer than 6,500 cases, primarily including patient populations with conditions such as severe community-acquired pneumonia (SCAP) and other ARDS-associated disorders;
- To collect comprehensive clinical data and multi-omics biological samples from these patients, constructing a high-quality multimodal ARDS database through rigorous data governance;
- Based on this foundation, to develop and clinically validate an ARDS-specific large-scale disease model to assist in clinical decision-making for early warning, diagnosis, and prognosis prediction, thereby improving the overall standard of ARDS management.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Behavioral: Clinical data and biospecimen collectionPatients meeting the 2024 global new definition of ARDS. |
| High-risk ARDS patients | – | Behavioral: Clinical data and biospecimen collectionPatients admitted to the ICU who do not meet ARDS diagnostic criteria but present with established ARDS risk factors, including: SCAP,, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, and aspiration.The primary etiology in this cohort is SCAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. ARDS ptients; 2. ARDS high-risk patients
Key inclusion criteria (27 listed)
- 1. ARDS Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Meets the 2024 Global New Definition of ARDS (diagnosis confirmed by at least two experienced physicians; in case of disagreement, a third physician will adjudicate):Diagnostic Criteria:
- Risk Factors \& Origin of Pulmonary Edema:Acute risk factors (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, shock).
- Pulmonary edema not fully or primarily attributable to cardiogenic pulmonary edema/fluid overload.Hypoxemia/gas exchange abnormalities not primarily due to atelectasis.Exception: ARDS can still be diagnosed if predisposing risk factors exist, even with concurrent conditions.
- Timing:Acute onset or worsening of hypoxemic respiratory failure within 7 days of risk factor exposure or new/worsening respiratory symptoms.
- Chest Imaging (X-ray/CT/US):Bilateral opacities (not fully explained by effusions, atelectasis, or nodules/masses)；Ultrasound findings: Bilateral B-lines and/or consolidations.
Key exclusion criteria (7 listed)
- Patients without ARDS or ARDS high-risk factors.
- Age <18 years.
- Incomplete clinical data.
- Refusal to sign informed consent.
- Long-term nursing home residents.
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 |
|---|---|---|
| Clinical data and biospecimen collectionClinical Data Collection: Case report forms were utilized to systematically capture multimodal clinical data, including: demographic characteristics, clinical symptoms and physical signs, laboratory test results, chest imaging data, organ support parameters, pharmacological interventions , complications and clinical outcomes. Biospecimen Collection: ARDS patients underwent biospecimen collection at days 1, 4, and 7 post-diagnosis. High-risk ARDS cohorts provided specimens within 24 hours of ICU admission. Specimens included: peripheral blood, Sputum/BALF, stool and urine. | Behavioural | ARDS, High-risk ARDS patients |
Primary outcome
ICU mortality
Time frame: From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the time frame would be 20 days.)
Hospital mortality
Time frame: From the time of patient enrollment until hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)
5 secondary outcomes
ICU length of stay
Time frame: From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the observation time frame would be 20 days.)
Hospital length of stay
Time frame: From enrollment to hospital discharge(For example: If a patient is enrolled in the study and remains in the hospital for 20 days before discharge, then the observation time frame would be 20 days.)
Mortality rates at 28 days post-enrollment
Time frame: From patient enrollment until 28 days post-enrollment
Mortality rates at 60 days post-enrollment
Time frame: From patient enrollment until 60 days post-enrollment
Mortality rates at 90 days post-enrollment
Time frame: From patient enrollment until 90 days post-enrollment
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 15 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Acute and Severe Community-Acquired Pneumonia, run by China-Japan Friendship Hospital.
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 27 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hangyong He (86+13693585722, yonghang2004@sina.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: From the time of patient enrollment until ICU discharge(For example: If a patient is enrolled in the study and remains in the ICU for 20 days before discharge, then the time frame would be 20 days.)). 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?
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 15 May 2025.