Acute Respiratory Distress Syndrome (ARDS)NCT07380997
Multi-Omics Integrative Analysis of Serum and Sputum to Uncover Key Determinants of Prognosis in Patients With ARDS
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Microbiome Dysbiosis, run by Ruijin Hospital.
Trial summary
This study is a prospective observational investigation designed to systematically characterize key microbial signatures, metabolite profiles, and gene-expression features in serum and sputum from patients with acute respiratory distress syndrome (ARDS), and to evaluate their associations with response to invasive… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Microbiome Dysbiosis, Multiomics Analysis
- How many people
- 411 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2029
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patients admitted to the intensive care unit(s) at Ruijin Hospital who require ventilation for ARDS (Berlin definition) or acute respiratory failure without ARDS, and are eligible for biospecimen collection (plasma from residual clinical venous blood and sputum) and clinical data collection
Who may be able to join
- Written and dated informed consent provided.
- Age ≥18 years.
- ARDS diagnosed according to the 2012 Berlin definition.
- Clinically stable
- eligible for enrollment after 12-24 hours of stability.
- Baseline oxygenation index (PaO2/FiO2 ≤300 mmHg)
- No history of major chronic lung disease and no history of immunosuppression.
- Able to comply with study procedures, including collection of blood/plasma and sputum samples and clinical data.
Who cannot join
- Severe autoimmune disease or active systemic inflammatory disease.
- Severe hepatic dysfunction or renal failure requiring dialysis.
- Invasive mechanical ventilation for >36 hours prior to enrollment, or death prior to enrollment.
- Expected death within 24 hours of admission or inability to complete study-related assessments due to imminent death.
- Presence of a cardiac pacemaker or other implanted electronic device that may affect respiratory function assessment.
- Pregnant or breastfeeding women.
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- Severe allergy to materials required for sample collection or other relevant contraindications.
- Severe psychiatric illness or inability to cooperate with study procedures.
- Prior participation in other interventional clinical trials that could affect interpretation of study results.
- Refusal of consent or withdrawal of informed consent.
About this study
This study is a prospective observational investigation designed to systematically characterize key microbial signatures, metabolite profiles, and gene-expression features in serum and sputum from patients with acute respiratory distress syndrome (ARDS), and to evaluate their associations with response to invasive mechanical ventilation and clinical outcomes. A total of 411 adult ARDS patients meeting the Berlin definition and receiving invasive mechanical ventilation will be enrolled; individuals with significant pre-existing pulmonary disease or a history of immunosuppression will be excluded. Blood and sputum specimens will undergo high-throughput sequencing and metabolomics, including 16S rRNA-based microbiome profiling, whole-transcriptome RNA sequencing, and targeted/untargeted metabolite quantification by LC-MS/MS. Ventilator-related parameters (e.g., tidal volume, positive end-expiratory pressure [PEEP], and respiratory system compliance) and clinical endpoints (e.g., 28-day mortality) will be integrated to establish a comprehensive multi-omics analytical framework.
Data preprocessing will include batch-effect correction, normalization, and multiple-testing adjustment with false discovery rate control (FDR < 0.05). Differential microbes, metabolites, and transcripts will be functionally interpreted using KEGG pathway and Gene Ontology (GO) enrichment analyses. Spearman correlation analyses will be performed to examine associations between omics features and ventilator parameters. Key features will be selected using LASSO regression, followed by development of random forest and support vector machine (SVM) models to predict mechanical ventilation response and the risk of ventilator-induced lung injury (VILI). Model performance will be assessed using ROC curves, area under the curve (AUC), calibration plots, and decision curve analysis.
By integrating serum and sputum multi-omics data, this study aims to identify molecular biomarkers that influence the effectiveness of mechanical ventilation and prognosis in ARDS, thereby providing evidence to support precision ventilatory strategies and individualized clinical management to improve patient outcomes. The findings are expected to deepen mechanistic understanding of ARDS pathobiology and lay a foundation for future development of multi-omics-guided diagnostic and therapeutic approaches.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Microbiome Dysbiosis, Multiomics Analysis, Metabolomics
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARDS Group | Adult patients (≥18 years) with acute respiratory distress syndrome (ARDS) diagnosed according to the Berlin definition. Serum/plasma and sputum biospecimens and relevant clinical/ventilator data will be collected for multi-omics profiling and outcome association analyses. | |
| Respiratory Failure Without ARDS Group | Adult patients (≥18 years) with acute respiratory failure who do not meet the Berlin criteria for ARDS. Serum/plasma and sputum biospecimens and relevant clinical/ventilator data will be collected for comparative multi-omics analyses and outcome association analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-Cause Mortality
All-cause mortality within 28 days after enrollment. Survival status will be ascertained via the hospital information system and, if needed, confirmed by telephone follow-up with family members. The observation window is from the date of enrollment (Day 0) through Day 28.
Measured: From enrollment (Day 0) to Day 28 post-enrollment (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 411 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jialinliu, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380997
- Sponsor's protocol ID
- RJ2025NO651
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Integrative Analysis of Serum and Sputum to Uncover Key Determinants of Prognosis in Patients With ARDS
- ClinicalTrials.gov ID
- NCT07380997
- Acronym / sponsor ID
- RJ2025NO651
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Microbiome Dysbiosis, Multiomics Analysis, Metabolomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 411 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Feb 2026 (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.
This study is a prospective observational investigation designed to systematically characterize key microbial signatures, metabolite profiles, and gene-expression features in serum and sputum from patients with acute respiratory distress syndrome (ARDS), and to evaluate their associations with response to invasive mechanical ventilation and clinical outcomes. A total of 411 adult ARDS patients meeting the Berlin definition and receiving invasive mechanical ventilation will be enrolled; individuals with significant pre-existing pulmonary disease or a history of immunosuppression will be excluded. Blood and sputum specimens will undergo high-throughput sequencing and metabolomics, including 16S rRNA-based microbiome profiling, whole-transcriptome RNA sequencing, and targeted/untargeted metabolite quantification by LC-MS/MS. Ventilator-related parameters (e.g., tidal volume, positive end-expiratory pressure [PEEP], and respiratory system compliance) and clinical endpoints (e.g., 28-day mortality) will be integrated to establish a comprehensive multi-omics analytical framework.
Data preprocessing will include batch-effect correction, normalization, and multiple-testing adjustment with false discovery rate control (FDR < 0.05). Differential microbes, metabolites, and transcripts will be functionally interpreted using KEGG pathway and Gene Ontology (GO) enrichment analyses. Spearman correlation analyses will be performed to examine associations between omics features and ventilator parameters. Key features will be selected using LASSO regression, followed by development of random forest and support vector machine (SVM) models to predict mechanical ventilation response and the risk of ventilator-induced lung injury (VILI). Model performance will be assessed using ROC curves, area under the curve (AUC), calibration plots, and decision curve analysis.
By integrating serum and sputum multi-omics data, this study aims to identify molecular biomarkers that influence the effectiveness of mechanical ventilation and prognosis in ARDS, thereby providing evidence to support precision ventilatory strategies and individualized clinical management to improve patient outcomes. The findings are expected to deepen mechanistic understanding of ARDS pathobiology and lay a foundation for future development of multi-omics-guided diagnostic and therapeutic approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS Group | – | –Adult patients (≥18 years) with acute respiratory distress syndrome (ARDS) diagnosed according to the Berlin definition. Serum/plasma and sputum biospecimens and relevant clinical/ventilator data will be collected for multi-omics profiling and outcome association analyses. |
| Respiratory Failure Without ARDS Group | – | –Adult patients (≥18 years) with acute respiratory failure who do not meet the Berlin criteria for ARDS. Serum/plasma and sputum biospecimens and relevant clinical/ventilator data will be collected for comparative multi-omics analyses and outcome association analyses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit(s) at Ruijin Hospital who require ventilation for ARDS (Berlin definition) or acute respiratory failure without ARDS, and are eligible for biospecimen collection (plasma from residual clinical venous blood and sputum) and clinical data collection
Key inclusion criteria (8 listed)
- Written and dated informed consent provided.
- Age ≥18 years.
- ARDS diagnosed according to the 2012 Berlin definition.
- Clinically stable
- eligible for enrollment after 12-24 hours of stability.
Key exclusion criteria (10 listed)
- Severe autoimmune disease or active systemic inflammatory disease.
- Severe hepatic dysfunction or renal failure requiring dialysis.
- Invasive mechanical ventilation for >36 hours prior to enrollment, or death prior to enrollment.
- Expected death within 24 hours of admission or inability to complete study-related assessments due to imminent death.
- Presence of a cardiac pacemaker or other implanted electronic device that may affect respiratory function assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-Day All-Cause Mortality
Time frame: From enrollment (Day 0) to Day 28 post-enrollment (28 days)
All-cause mortality within 28 days after enrollment. Survival status will be ascertained via the hospital information system and, if needed, confirmed by telephone follow-up with family members. The observation window is from the date of enrollment (Day 0) through Day 28.
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 2 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Microbiome Dysbiosis, run by Ruijin 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 8 inclusion and 10 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 2 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day All-Cause Mortality (time frame: From enrollment (Day 0) to Day 28 post-enrollment (28 days)). 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 2 Feb 2026.