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Clinical Trials/NCT05058768
NCT05058768
Recruiting
Not Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country180 target enrollmentMay 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lung Injury
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
180
Locations
1
Primary Endpoint
Compare the omics differences of blood samples between the experimental and control groups
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2022
End Date
December 16, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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 Outcomes

  • Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups(one year)

Study Sites (1)

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