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

Recruiting

• Conditions: Acute Lung Injury
• Interventions: Diagnostic Test: The lungs causes and extrapulmonary factors

• Registration Number: NCT05058768
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-28
• Study Start: 2022-05-06
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10
• Primary Completion: 2023-05-07
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experimental group	The lungs causes and extrapulmonary factors	Patients with acute lung injury were treated as the experimental group.

Primary Outcome Measures

Name	Time	Method
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 .
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

Name	Time	Method
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 .

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China