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Study on the Correlation Between Alveolar Macrophage-derived Autophagosomes and the Severity of Lung Injury in ARDS

17. juli 2022 opdateret af: Ling Liu, Southeast University, China
In the process of acute respiratory distress syndrome (ARDS), alveolar macrophages can secrete a large number of autophagosomes to mediate the inflammatory response of ARDS and aggravate the pathological damage of the lungs. At the same time, the meta-transcriptome can detect the expression of all genes without a reference genome. This study intends to explore that Whether the alveoli macrophage-derived autophagosomes are related to the severity and prognosis of ARDS, and try to construct a recognition model to predict the prognosis of ARDS.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Nowadays, acute respiratory distress syndrome (ARDS) is a major clinical problem in the world. Infection and other factors induce immune cells to release inflammatory mediators, and the following uncontrolled inflammatory response is the fundamental reason for the poor prognosis of ARDS. So, it's important to explore the mechanism of ARDS and reduce lung injury.

In the lung tissue, the activation of alveolar macrophages (including alveolar resident macrophages and macrophages recruited in the blood) is an important way that mediates the ARDS inflammatory response. The previous study of the investigator's team proved that alveolar macrophages could not only directly secrete inflammatory mediators, but also mediated the release of inflammatory factors through the secretion of autophagosomes. At the same time, ARDS has been extensively studied in molecular biology, but the prospective exploration of the relationship between the host response and the development mechanism of ARDS is lacking.

The formation of autophagosomes is the marker of autophagy. In the process of ARDS, alveolar macrophages can secrete a large number of autophagosomes to mediate the inflammatory response of ARDS and aggravate the pathological damage of the lungs. At the same time, the meta-transcriptome can detect the expression of all genes without a reference genome, so it has an irreplaceable advantage in exploring the host's response when pathogenic microorganisms invade the body. The investigators speculate that there may be differences in the host response between patients with different types of ARDS.

However, the above results are derived from cell or animal experiments. It hasn't been known whether autophagosomes could be secreted in the alveoli of ARDS patients, and it has not been proven that whether there is a difference in host response between ARDS patients and controls. Therefore, this study intends to explore that Whether the alveoli macrophage-derived autophagosomes are related to the severity and prognosis of ARDS, and try to construct a recognition model to predict the prognosis of ARDS.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210009
        • Rekruttering
        • Nanjing Zhong-Da Hospital, Southeast University

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 til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients diagnosed with ARDS in the Department of Critical Care Medicine, Zhongda Hospital, Southeast University from October 2021 to May 2022

Beskrivelse

Inclusion Criteria:

  1. Age 18-85 years old
  2. Meet ARDS Berlin diagnostic criteria
  3. Artificial airway has been established (tracheal intubation, tracheotomy)
  4. Sign informed consent
  5. Within 7 days of diagnosis of ARDS

Exclusion Criteria:

  1. Younger than 18 years old or older than 85 years old
  2. Pregnant women, cancer and immune system diseases
  3. There are contraindications for bronchoscopy (poor oxygenation/severe heart disease, cardiac insufficiency/abnormal blood clotting, massive hemoptysis/aortic aneurysm risk of rupture, etc.)
  4. Patients undergoing other clinical trials
  5. Estimated survival time <24h

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The link between the proportion of macrophage-derived autophagosomes in alveolar lavage fluid of ARDS patients with the severity of ARDS
Tidsramme: at the first day of enrolling the patients
Getting these data through Flow cytometer and analyzing the link between these data with the severity of ARDS
at the first day of enrolling the patients
Autophagosomes in alveolar lavage fluid of ARDS patients with the prognosis of ARDS
Tidsramme: at the twenty-eighth day of enrolling the patients
Getting these data through Flow cytometer and analyzing the link between these data with the prognosis of ARDS
at the twenty-eighth day of enrolling the patients

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Autophagosomes and macrophage-derived autophagosomes in blood
Tidsramme: day 1,day 3 or day 7
Getting these data through Flow cytometer and analyzing the link between these data with the prognosis of ARDS
day 1,day 3 or day 7
extracellular vesicles
Tidsramme: day 1,day 3 or day 7
extracellular vesicles in alveolar lavage fluid and blood through Flow cytometer
day 1,day 3 or day 7
Mortality
Tidsramme: During hospitalization
ICU, 28 day and hospital mortality
During hospitalization
length of stay
Tidsramme: During hospitalization
ICU and hospital length of stay
During hospitalization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Ling Liu, Dr, Southeast university

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. januar 2022

Primær færdiggørelse (Forventet)

30. december 2023

Studieafslutning (Forventet)

30. december 2023

Datoer for studieregistrering

Først indsendt

25. september 2021

Først indsendt, der opfyldte QC-kriterier

24. oktober 2021

Først opslået (Faktiske)

1. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2021ZDSYLL215-P01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

all the the data and methods can be shared with other researchers

IPD-delingstidsramme

the data can be available before June 2023 and can be available for all the time

IPD-delingsadgangskriterier

liulingdoctor@126.com

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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