Acute Respiratory Distress SyndromeNCT06825754
The Value of Serum MicroRNA-21-5p and LncRNAgadd7 Expression Levels in Predicting the Severity and Prognosis of ARDS ( Acute Respiratory Distress Syndrome )
An observational study of Acute Respiratory Distress Syndrome, run by Shao Yuekai at 1 site in China.
Trial summary
By measuring the expression levels of MicroRNA-21-5p (miR-21-5p) and LncRNAgadd7 in the peripheral blood of ARDS patients, the study aims to explore the correlation between these levels and the severity and prognosis of ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 10 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS ( Acute Respiratory Distress Syndrome)
Who may be able to join
- Age ≥ 18 years;
- Meets the Berlin Criteria for ARDS;
- Diagnosed with ARDS within 48 hours;
- Signed informed consent.
Who cannot join
- Immunosuppressed patients: including those on immunosuppressive drugs, history of stem cell transplantation, etc.;
- Patients with malignant tumors;
- Pregnant women;
- Patients discharged from the ICU within 48 hours;
- History of chronic lung diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563100
About this study
By measuring the expression levels of MicroRNA-21-5p (miR-21-5p) and LncRNAgadd7 in the peripheral blood of ARDS patients, the study aims to explore the correlation between these levels and the severity and prognosis of ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survival Group | Not described | |
| Death Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression levels of MicroRNA-21-5p (miR-21-5p)
Measured: 28 days
the expression levels of LncRNAgadd7
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Nov 2023
- Primary completion30 Nov 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shao Yuekai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shao Yuekai, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825754
- Sponsor's protocol ID
- KLLY-2023--198
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Serum MicroRNA-21-5p and LncRNAgadd7 Expression Levels in Predicting the Severity and Prognosis of ARDS ( Acute Respiratory Distress Syndrome )
- ClinicalTrials.gov ID
- NCT06825754
- Acronym / sponsor ID
- KLLY-2023--198
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shao YuekaiUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 13 Feb 2025 (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.
By measuring the expression levels of MicroRNA-21-5p (miR-21-5p) and LncRNAgadd7 in the peripheral blood of ARDS patients, the study aims to explore the correlation between these levels and the severity and prognosis of ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survival Group | – | – |
| Death Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS ( Acute Respiratory Distress Syndrome)
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Meets the Berlin Criteria for ARDS;
- Diagnosed with ARDS within 48 hours;
- Signed informed consent.
Key exclusion criteria (5 listed)
- Immunosuppressed patients: including those on immunosuppressive drugs, history of stem cell transplantation, etc.;
- Patients with malignant tumors;
- Pregnant women;
- Patients discharged from the ICU within 48 hours;
- History of chronic lung diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The expression levels of MicroRNA-21-5p (miR-21-5p)
Time frame: 28 days
the expression levels of LncRNAgadd7
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Distress Syndrome, run by Shao Yuekai 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression levels of MicroRNA-21-5p (miR-21-5p) (time frame: 28 days). 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 13 Feb 2025.