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Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes

Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying the Endotypes in Patients With ARDS

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05451342
Enrollment
200
Registered
2022-07-11
Start date
2022-02-15
Completion date
2024-06-15
Last updated
2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Respiratory Failure

Keywords

ARDS, biomarkers, immunometabolism

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTIntegrated Transcriptomics, Metabolomics, and Lipidomics Profiling

Blood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged \>18 years old; 2. Meet the diagnostic criteria of ARDS according to the Berlin Criteria.

Exclusion criteria

1. Aged≤18 years old; 2. Pregnancy; 3. No informed consent;

Design outcomes

Primary

MeasureTime frameDescription
Identification of ARDS Endotypes2 yearsBlood 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.

Secondary

MeasureTime frameDescription
Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS2 yearsPlasma and BLAF supernatant are used for exosome extraction
Correlation of Endotypes with published ARDS specific Biomarkers2 yearsCorrelate the endotypes with published markers of hyperinflammatory, microvascular-injury predominant, and distal lung epithelial cell-predominant injury in ARDS
Correlation of Endotypes with Intensive care unit-free daysUntil 28 days following ICU admissionIntensive 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.
Correlation of Endotypes with Ventilator-free daysUntil 28 days following ICU admissionVentilator-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.
Correlation of Endotypes with All-cause mortalityUntil death or hospital discharge, assessed up to 28 days following ICU admission

Countries

China

Contacts

Primary ContactYingying Yang, MD
yangyingying2703@outlook.com+8618800173833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026