Clinical trial NCT05058768: Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury
Official title: Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the omics differences of blood samples between the experimental and control groups
timeFrame: one year
measure: Compare the omics differences of urine samples between the experimental and control groups
timeFrame: one year
Secondary outcomes:
measure: Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: linzhong yu, professor
role: STUDY_CHAIR
References: