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

Sponsor
Southeast University, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05101694
Collaborator
(none)
60
1
23.9
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Study on the Correlation Between Alveolar Macrophage-derived Autophagosomes and the Severity of Lung Injury in ARDS
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The link between the proportion of macrophage-derived autophagosomes in alveolar lavage fluid of ARDS patients with the severity of ARDS [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

    2. Autophagosomes in alveolar lavage fluid of ARDS patients with the prognosis of ARDS [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

    Secondary Outcome Measures

    1. Autophagosomes and macrophage-derived autophagosomes in blood [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

    2. extracellular vesicles [day 1,day 3 or day 7]

      extracellular vesicles in alveolar lavage fluid and blood through Flow cytometer

    3. Mortality [During hospitalization]

      ICU, 28 day and hospital mortality

    4. length of stay [During hospitalization]

      ICU and hospital length of stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Zhong-Da Hospital, Southeast University Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

    • Study Director: Ling Liu, Dr, Southeast University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ling Liu, professor, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT05101694
    Other Study ID Numbers:
    • 2021ZDSYLL215-P01
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ling Liu, professor, Southeast University, China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2022