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

Acute Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058768
• Other study ID #: NFEC-2021-143
• Status: Recruiting
• Start date: May 6, 2022
• Est. completion date: December 16, 2024

Study information

• Verified date: September 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: zhuping M zheng, bachelor
• Phone: 18680263256
• Email: zhengzhuping007[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 16, 2024
• Est. primary completion date: May 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury

Intervention

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.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the omics differences of blood samples between the experimental and control groups	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
Primary	Compare the omics differences of urine samples between the experimental and control groups	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	Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups	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