Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes
5. juli 2022 opdateret af: Peking Union Medical College Hospital
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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yingying Yang, MD
- Telefonnummer: +8618800173833
- E-mail: yangyingying2703@outlook.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100000
- Rekruttering
- PUMC
-
Kontakt:
- Hui Xu, MD
- Telefonnummer: 01069156874
- E-mail: pumchkyc@163.com
-
Beijing, Beijing, Kina, 100730
- Rekruttering
- Yingying Yang
-
Kontakt:
- Yingying Yang
- Telefonnummer: +8618800173833
- E-mail: yangyingying2703@outlook.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
ICU patients with the diagnosis of ARDS
Beskrivelse
Inclusion Criteria:
- Aged >18 years old;
- Meet the diagnostic criteria of ARDS according to the Berlin Criteria.
Exclusion Criteria:
- Aged≤18 years old;
- Pregnancy;
- No informed consent;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
ARDS
Patients who meet the diagnostic criteria of ARDS
|
Blood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction.
|
|
Non-ARDS
Patients without ARDS
|
Blood samples and BALD samples will be collected for further integrated transcriptomics, metabolomics, lipidomics analysis, and exosome extraction.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification of ARDS Endotypes
Tidsramme: 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.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS
Tidsramme: 2 years
|
Plasma and BLAF supernatant are used for exosome extraction
|
2 years
|
|
Correlation of Endotypes with published ARDS specific Biomarkers
Tidsramme: 2 years
|
Correlate the endotypes with published markers of hyperinflammatory, microvascular-injury predominant, and distal lung epithelial cell-predominant injury in ARDS
|
2 years
|
|
Correlation of Endotypes with Intensive care unit-free days
Tidsramme: Until 28 days following ICU admission
|
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
|
|
Correlation of Endotypes with Ventilator-free days
Tidsramme: Until 28 days following ICU admission
|
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
|
|
Correlation of Endotypes with All-cause mortality
Tidsramme: Until death or hospital discharge, assessed up to 28 days following ICU admission
|
Until death or hospital discharge, assessed up to 28 days following ICU admission
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Yun Long, MD, Peking Union Medical College
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. februar 2022
Primær færdiggørelse (Forventet)
15. februar 2024
Studieafslutning (Forventet)
15. juni 2024
Datoer for studieregistrering
Først indsendt
27. juni 2022
Først indsendt, der opfyldte QC-kriterier
5. juli 2022
Først opslået (Faktiske)
11. juli 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juli 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ZS-3391
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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