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

NCT05058768 | Unknown

• 1 other identifier: NFEC-2021-143
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups

  one year

Study Arms (2)

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

Interventions

The lungs causes and extrapulmonary factors DIAGNOSTIC_TEST

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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine or alveolar lavage fluid samples of the experimental group and the control group were reserved for omics sequencing

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• linzhong yu, professor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

zhuping M zheng, bachelor

CONTACT

18680263256; zhengzhuping007@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 28, 2021
• Study Start: May 6, 2022
• Primary Completion: May 7, 2023
• Study Completion: December 16, 2024
• Last Updated: May 10, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)