Acute Lung InjuryNCT05058768
Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury
An observational study of Acute Lung Injury, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- The lungs causes and extrapulmonary factors
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2022to 16 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 (㎡);
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
zhuping zheng, bachelor, 18680263256, zhengzhuping007@163.com
About this study
Official title: Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics
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.
Read the 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.
- Conditions
- Acute Lung Injury
- Being tested
- The lungs causes and extrapulmonary factors
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The lungs causes and extrapulmonary factorsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Healthy people served as the control group | |
| experimental group | Patients with acute lung injury were treated as the experimental group. Receives: Diagnostic Test: The lungs causes and extrapulmonary factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: one year
Secondary outcomes (1)
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 .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start6 May 2022 (estimated)
- Primary completion7 May 2023 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- linzhong yu, professor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058768
- Sponsor's protocol ID
- NFEC-2021-143
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics
- ClinicalTrials.gov ID
- NCT05058768
- Acronym / sponsor ID
- NFEC-2021-143
- Conditions
- Acute Lung Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (estimated)
- Primary completion
- 7 May 2023 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Healthy people served as the control group |
| experimental group | – | Diagnostic Test: The lungs causes and extrapulmonary factorsPatients with acute lung injury were treated as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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 (㎡);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The lungs causes and extrapulmonary factorsAcute 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. | Diagnostic test | experimental group |
Primary outcome
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 .
1 secondary outcome
Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
linzhong yu, professor study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhuping M zheng, bachelor (18680263256, zhengzhuping007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the omics differences of blood samples between the experimental and control groups (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.