Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury

May 9, 2022 updated by: Nanfang Hospital of Southern Medical University

Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics

The exosomes in the experimental group and the control group were sequenced to find the difference of the two groups, providing a basis for subsequent basic research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an observational study, mainly collected by infection, trauma, burns and other non cardiac causes without any related comprehensive character drug treatment of acute respiratory distress (ARDS) in patients with blood, urine or alveolar lavage fluid specimens, used to extract exosomes for omics sequencing, relevant histomorphic variations in exosomes of this disease were obtained, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research.

Study Type

Observational

Enrollment (Anticipated)

180

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The experimental group was patients with acute lung injury, which was caused by various direct and indirect injury factors of alveolar epithelial cells and capillary endothelial cells, resulting in diffuse pulmonary interstitial and alveolar edema, resulting in acute hypoxic respiratory insufficiency. The control group was healthy subjects.

Description

Inclusion Criteria:

Inclusion criteria of experimental group:

  • Signed informed consent voluntarily;
  • Age: >18 years old, gender: no restrictions ;
  • Patients with known clinical manifestations of respiratory impairment or new/aggravated respiratory symptoms diagnosed within one week of onset according to the Berlin definition guidelines.

Control group inclusion criteria:

  • Age ≥18 years old (including 18 years old), male and female;
  • Male weight ≥50 kg, female weight ≥45kg, and body mass index (BMI) between 19 and 26(inclusive), BMI= weight (kg)/ height (㎡);
  • No smoking, alcohol addiction, no history of drug abuse;
  • No diabetes, asthma, copd, chronic renal insufficiency and other basic diseases; No history of major diseases or infectious diseases (including hepatitis B, hepatitis C, HIV, syphilis);
  • Those who have not taken drugs recently.

Exclusion Criteria:

Exclusion criteria of experimental group:

  • Patients with diabetes, chronic renal insufficiency, malignant tumors and other basic diseases;
  • severe malnutrition;
  • Pregnant or lactating women;
  • The researcher judged that he was not suitable to participate in this study.

Exclusion criteria for the control group:

  • pregnant or lactation women;
  • severe malnutrition;
  • The researcher judged that he was not suitable to participate in this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
Healthy people served as the control group
experimental group
Patients with acute lung injury were treated as the experimental group.
Diagnostic test: The lungs causes and extrapulmonary factors
Acute lung injury due to internal and external pulmonary causes can be used as intervention items in this study, and intervention items can be excluded according to inclusion criteria and exclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the omics differences of blood samples between the experimental and control groups
Time Frame: one year
Collected separately in the experimental group and the control group participants' blood as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research .
one year
Compare the omics differences of urine samples between the experimental and control groups
Time Frame: one year
Collected separately in the experimental group and the control group participants' urine as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research .
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups
Time Frame: one year
Collected separately in the experimental group and the control group participants' alveolar lavage fluid as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research .
one year

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Study Chair: linzhong yu, professor, Nanfang Hospital of Southern Medical University

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 (Anticipated)

May 6, 2022

Primary Completion (Anticipated)

May 7, 2023

Study Completion (Anticipated)

December 16, 2024

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2021-143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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