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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058768
Collaborator
(none)
180
1
31.4
5.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The lungs causes and extrapulmonary factors

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 Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics
Anticipated Study Start Date :
May 6, 2022
Anticipated Primary Completion Date :
May 7, 2023
Anticipated Study Completion Date :
Dec 16, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Compare the omics differences of blood samples between the experimental and control groups [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 .

  2. Compare the omics differences of urine samples between the experimental and control groups [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 .

Secondary Outcome Measures

  1. Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT05058768
Other Study ID Numbers:
  • NFEC-2021-143
First Posted:
Sep 28, 2021
Last Update Posted:
May 10, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022