Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDSNCT03296761
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury
An observational study of Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS, run by Jingyuan,Xu at 1 site in China.
Trial summary
To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 20 Feb 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS
Who may be able to join
- Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h
- Patients age between 18 years old and 80 years.
Who cannot join
- Pregnant women,
- Patients with malignant tumor,
- Immunosuppression or immunocompromised patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Yuanyuan YU, 15651680953, 220153911@seu.edu.cn
About this study
To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.
Read the detailed description
70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.
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 |
|---|---|---|
| ESM-1<5ng/ml | Not described | |
| ESM-1≥5ng/ml | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Nov 2017 (estimated)
- Primary completion20 Dec 2017 (estimated)
- Study completion20 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDSStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingyuan,Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Haibo qiu, Study chair, Zhong-Da Hospital, School of Medicine, Southeast University,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296761
- Sponsor's protocol ID
- 2017ZDSYLL081-P01
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury
- ClinicalTrials.gov ID
- NCT03296761
- Acronym / sponsor ID
- 2017ZDSYLL081-P01
- Conditions
- Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jingyuan,XuUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 20 Feb 2018 (estimated)
- First posted
- 28 Sep 2017 (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.
To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.
Detailed description
70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESM-1<5ng/ml | – | – |
| ESM-1≥5ng/ml | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS
Key inclusion criteria (2 listed)
- Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h
- Patients age between 18 years old and 80 years.
Key exclusion criteria (3 listed)
- Pregnant women,
- Patients with malignant tumor,
- Immunosuppression or immunocompromised patients.
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
mortality
Time frame: 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No
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.
Haibo qiu study chair
Zhong-Da Hospital, School of Medicine, Southeast 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 Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS, run by Jingyuan,Xu 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 2 inclusion and 3 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 1 Nov 2017. 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 Yuanyuan YU (15651680953, 220153911@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28-day). 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 1 Nov 2017.