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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451342
• Other study ID #: ZS-3391
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: June 2022
• Source: Peking Union Medical College Hospital
• Contact: Yingying Yang, MD
• Phone: +8618800173833
• Email: yangyingying2703[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Integrated Transcriptomics, Metabolomics, and Lipidomics Profiling
Blood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction.

Locations

Country	Name	City	State
China	PUMC	Beijing	Beijing
China	Yingying Yang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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.	Until 28 days following ICU admission
Secondary	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.	Until 28 days following ICU admission
Secondary	Correlation of Endotypes with All-cause mortality		Until death or hospital discharge, assessed up to 28 days following ICU admission