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

July 17, 2022 updated by: 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Nanjing Zhong-Da Hospital, Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The link between the proportion of macrophage-derived autophagosomes in alveolar lavage fluid of ARDS patients with the severity of ARDS
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autophagosomes and macrophage-derived autophagosomes in blood
Time Frame: 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
Time Frame: 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
Time Frame: During hospitalization
ICU, 28 day and hospital mortality
During hospitalization
length of stay
Time Frame: During hospitalization
ICU and hospital length of stay
During hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Study Director: Ling Liu, Dr, Southeast university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 25, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021ZDSYLL215-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

liulingdoctor@126.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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