Clinical trial NCT05451342: Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes
Official title: Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying the Endotypes in Patients With ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Acute Respiratory Failure
Keywords: ARDS, biomarkers, immunometabolism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with the diagnosis of ARDS

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Identification of ARDS Endotypes
timeFrame: 2 years
Secondary outcomes:
measure: Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS
timeFrame: 2 years
measure: Correlation of Endotypes with published ARDS specific Biomarkers
timeFrame: 2 years
measure: Correlation of Endotypes with Intensive care unit-free days
timeFrame: Until 28 days following ICU admission
measure: Correlation of Endotypes with Ventilator-free days
timeFrame: Until 28 days following ICU admission
measure: Correlation of Endotypes with All-cause mortality
timeFrame: Until death or hospital discharge, assessed up to 28 days following ICU admission
Other outcomes:
Locations:
city: Beijing
country: China
facility: PUMC
state: Beijing
city: Beijing
country: China
facility: Yingying Yang
state: Beijing
Study officials:
affiliation: Peking Union Medical College
name: Yun Long, MD
role: STUDY_DIRECTOR
References: