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Multimodal Database and Large Language Model for ARDS

ConditionsRespiratory Distress Syndrome, AcuteSevere Community-Acquired Pneumonia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Risk Factors & Origin of Pulmonary Edema:Acute risk factors (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, shock).

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.

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.

Disqualifiers

Patients without ARDS or ARDS high-risk factors.

Age <18 years.

Incomplete clinical data.

Refusal to sign informed consent.

Trial population

1. ARDS ptients; 2. ARDS high-risk patients

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Clinical data and biospecimen collection

    Behavioral

    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.

Treatment groups

6,500 Participants
are divided into 2 treatment groups
Group A: ARDS1 intervention
Group B: High-risk ARDS patients1 intervention

Trial outcomes

Primary outcomes

1

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.)
2

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.)

Secondary outcomes

1

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.)
2

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.)
3

Mortality rates at 28 days post-enrollment

Time frame
From patient enrollment until 28 days post-enrollment
4

Mortality rates at 60 days post-enrollment

Time frame
From patient enrollment until 60 days post-enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: