Acute Respiratory Distress SyndromeNCT05451342
Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes
An observational study of Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a life-threatening condition that causes high mortality (41% to 58%). Previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ARDS, enabling precision treatment of ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- What is being tested?
- Integrated Transcriptomics, Metabolomics, and Lipidomics Profiling
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 15 Feb 2022to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: ICU patients with the diagnosis of ARDS
Who may be able to join
- Aged >18 years old;
- Meet the diagnostic criteria of ARDS according to the Berlin Criteria.
Who cannot join
- Aged≤18 years old;
- Pregnancy;
- No informed consent;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
PUMC
Beijing, Beijing Municipality, 100000
Hui Xu, MD, 01069156874, pumchkyc@163.com
- Recruiting
Yingying Yang
Beijing, Beijing Municipality, 100730
Yingying Yang, +8618800173833, yangyingying2703@outlook.com
About this study
Official title: Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying the Endotypes in Patients With ARDS
Acute respiratory distress syndrome (ARDS) is a life-threatening condition that causes high mortality (41% to 58%). Previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ARDS, enabling precision treatment of ARDS. Although there were many studies that found some potential therapeutic targets for ARDS, no pharmacotherapies have been validated to treat ARDS. The development of biomarkers to predict the prognosis and monitor the response to treatment would be of interest for selecting patients for specific therapeutic trials. Many recent studies have shown that immune metabolic changes are involved in the pathogenesis of ARDS and may become a new therapeutic target for them. We aimed to identify a panel of immunometabolic and lipidomic biomarkers derived from blood and bronchoalveolar lavage fluid (BALF) which may help differentiate the ARDS endotypes.
Read the detailed description
PROTOCOL OUTLINE:
This is an observational study. The blood and BALF samples will be collected from patients with ARDS for exosome extraction and transcriptome and metabolomic analysis.
Exosome characterization and differential genes and metabolites will be identified.
- Being tested
- Integrated Transcriptomics, Metabolomics, and Lipidomics Profiling
- Keywords
- ARDS, biomarkers, immunometabolism
- 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.
Integrated Transcriptomics, Metabolomics, and Lipidomics ProfilingDiagnostic test
Blood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction.
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Patients who meet the diagnostic criteria of ARDS Receives: Diagnostic Test: Integrated Transcriptomics, Metabolomics, and Lipidomics Profiling | |
| Non-ARDS | Patients without ARDS Receives: Diagnostic Test: Integrated Transcriptomics, Metabolomics, and Lipidomics Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of ARDS Endotypes
Blood samples will be collected on day 1, 3, 5,7 since ARDS diagnosis is made (day 0) and BALF samples will be collected on day 1 and day 7. Blood samples are used to extract PBMC and BALF samples are used to extract alveolar macrophage. Afterwards, PBMC and alveolar macrophage are saved for further transcriptomic and metabomic analysis. At the same time, clinical and biological date are collected to identify subgroups of patients that might share mortality risk, clinical course, and/or treatment responsiveness. At last, the relationship between transcriptomic and metabomic signature of PBMC and alveolar macrophage and the clinical phenotypes are analyzed to determine ARDS endotypes.
Measured: 2 years
Secondary outcomes (5)
Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS
Plasma and BLAF supernatant are used for exosome extraction
Measured: 2 years
Correlation of Endotypes with published ARDS specific Biomarkers
Correlate the endotypes with published markers of hyperinflammatory, microvascular-injury predominant, and distal lung epithelial cell-predominant injury in ARDS
Measured: 2 years
Correlation of Endotypes with Intensive care unit-free days
Intensive care unit-free days are calculated by the number of days in the first 28 days following ICU admission that a patient is alive and not in the intensive care unit.
Measured: Until 28 days following ICU admission
Correlation of Endotypes with Ventilator-free days
Ventilator-free days are calculated by the number of days in the first 28 days following ICU admissionthat a patient is alive and not on a ventilator.
Measured: Until 28 days following ICU admission
Correlation of Endotypes with All-cause mortality
Measured: Until death or hospital discharge, assessed up to 28 days following ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Feb 2022
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Jun 2024 (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 SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study director, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451342
- Sponsor's protocol ID
- ZS-3391
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying the Endotypes in Patients With ARDS
- ClinicalTrials.gov ID
- NCT05451342
- Acronym / sponsor ID
- ZS-3391
- Keywords
- ARDS, biomarkers, immunometabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 11 Jul 2022 (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.
Acute respiratory distress syndrome (ARDS) is a life-threatening condition that causes high mortality (41% to 58%). Previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ARDS, enabling precision treatment of ARDS. Although there were many studies that found some potential therapeutic targets for ARDS, no pharmacotherapies have been validated to treat ARDS. The development of biomarkers to predict the prognosis and monitor the response to treatment would be of interest for selecting patients for specific therapeutic trials. Many recent studies have shown that immune metabolic changes are involved in the pathogenesis of ARDS and may become a new therapeutic target for them. We aimed to identify a panel of immunometabolic and lipidomic biomarkers derived from blood and bronchoalveolar lavage fluid (BALF) which may help differentiate the ARDS endotypes.
Detailed description
PROTOCOL OUTLINE:
This is an observational study. The blood and BALF samples will be collected from patients with ARDS for exosome extraction and transcriptome and metabolomic analysis.
Exosome characterization and differential genes and metabolites will be identified.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Diagnostic Test: Integrated Transcriptomics, Metabolomics, and Lipidomics ProfilingPatients who meet the diagnostic criteria of ARDS |
| Non-ARDS | – | Diagnostic Test: Integrated Transcriptomics, Metabolomics, and Lipidomics ProfilingPatients without ARDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with the diagnosis of ARDS
Key inclusion criteria (2 listed)
- Aged >18 years old;
- Meet the diagnostic criteria of ARDS according to the Berlin Criteria.
Key exclusion criteria (3 listed)
- Aged≤18 years old;
- Pregnancy;
- No informed consent;
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 |
|---|---|---|
| Integrated Transcriptomics, Metabolomics, and Lipidomics ProfilingBlood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction. | Diagnostic test | ARDS, Non-ARDS |
Primary outcome
Identification of ARDS Endotypes
Time frame: 2 years
Blood samples will be collected on day 1, 3, 5,7 since ARDS diagnosis is made (day 0) and BALF samples will be collected on day 1 and day 7. Blood samples are used to extract PBMC and BALF samples are used to extract alveolar macrophage. Afterwards, PBMC and alveolar macrophage are saved for further transcriptomic and metabomic analysis. At the same time, clinical and biological date are collected to identify subgroups of patients that might share mortality risk, clinical course, and/or treatment responsiveness. At last, the relationship between transcriptomic and metabomic signature of PBMC and alveolar macrophage and the clinical phenotypes are analyzed to determine ARDS endotypes.
5 secondary outcomes
Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS
Time frame: 2 years
Correlation of Endotypes with published ARDS specific Biomarkers
Time frame: 2 years
Correlation of Endotypes with Intensive care unit-free days
Time frame: Until 28 days following ICU admission
Correlation of Endotypes with Ventilator-free days
Time frame: Until 28 days following ICU admission
Correlation of Endotypes with All-cause mortality
Time frame: Until death or hospital discharge, assessed up to 28 days following ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- 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. This study is not recruiting at the moment.
Yun Long, MD study director
Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by Peking Union Medical College Hospital at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingying Yang, MD (+8618800173833, yangyingying2703@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of ARDS Endotypes (time frame: 2 years). 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 11 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.