ARDS, HumanNCT03854565
Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis
An observational study of ARDS, Human and Endothelial Dysfunction, run by Southeast University, China at 1 site in China.
Trial summary
ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Human, Endothelial Dysfunction, Mechanical Ventilation Pressure High
- What is being tested?
- Glycocalyx measurement，respiratory mechanics measurement
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Dec 2019
- How long will I take part?
- 6 Months
- 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
- Adult, Older adult
Study population: patients have been diagnosed ARDS with mechanical ventilation, and do not been used heparin, molecular heparin, chondroitin sulfuric acid.
Who may be able to join
- Age > 18yrs and <80yrs
- Meet ARDS Berlin definition
- With mechanical ventilation
Who cannot join
- have chronic pulmonary disease
- have use heparin or low molecular heparin or chondroitin sulfuric acid
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Chun Pan, Dr, +862583262550, panchun1982@gmail.com
About this study
Official title: Predictive Value of Glycocalyx Biomarkers in Mechanical Ventilation of Patients With ARDS for Clinical Prognosis and Long-term Pulmonary Fibrosis
ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury.
Decorin is a member of the small leucine-rich proteoglycan (SLRP) family, contains a single glycosaminoglycan (GAG) chain and a core protein with 12 leucine-rich repeats. In the previous study, decorin is associated with cardiac and liver fibrosis, however, the effects of decorin on ARDS pulmonary fibrosis have not been clarified.
- Being tested
- Glycocalyx measurement，respiratory mechanics measurement
- Keywords
- ARDS, Endothelial Dysfunction, mechanical ventilation, Glycocalyx, pulmonary fibrosis, mortality
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycocalyx measurement，respiratory mechanics measurementDiagnostic test
ELASA measure glycocalyx, measure plateau pressure, driving pressure
| Study group | Role | What they receive |
|---|---|---|
| Mild ARDS | patients have mild ARDS according to Berlin definition Receives: Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurement | |
| Moderate ARDS | patients have moderate ARDS according to Berlin definition Receives: Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurement | |
| Severe ARDS | patients have severe ARDS according to Berlin definition Receives: Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days mortality from patients involved in the study
28 days mortality from patients involved in the study
Measured: 28 days
Secondary outcomes (2)
CT and syndecan-1 to evaluate pulmonary fibrosis
pulmonary fibrosis evaluated by biomarker and CT
Measured: 1mon, 3mon and 6 month
pulmonary function test to evaluate pulmonary function
pulmonary function evaluated by pulmonary function test
Measured: 1mon, 3mon and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 May 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Prospective
- Enrolment
- 336 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Chun C Pan, Dr, Principal investigator, Zhongda hospital, Southeast University, Jiangsu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854565
- Sponsor's protocol ID
- Decorin-ARDS fibrosis study
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Glycocalyx Biomarkers in Mechanical Ventilation of Patients With ARDS for Clinical Prognosis and Long-term Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03854565
- Acronym / sponsor ID
- Decorin-ARDS fibrosis study
- Keywords
- ARDS, Endothelial Dysfunction, mechanical ventilation, Glycocalyx, pulmonary fibrosis, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury.
Decorin is a member of the small leucine-rich proteoglycan (SLRP) family, contains a single glycosaminoglycan (GAG) chain and a core protein with 12 leucine-rich repeats. In the previous study, decorin is associated with cardiac and liver fibrosis, however, the effects of decorin on ARDS pulmonary fibrosis have not been clarified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild ARDS | – | Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurementpatients have mild ARDS according to Berlin definition |
| Moderate ARDS | – | Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurementpatients have moderate ARDS according to Berlin definition |
| Severe ARDS | – | Diagnostic Test: Glycocalyx measurement，respiratory mechanics measurementpatients have severe ARDS according to Berlin definition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients have been diagnosed ARDS with mechanical ventilation, and do not been used heparin, molecular heparin, chondroitin sulfuric acid.
Key inclusion criteria (3 listed)
- Age > 18yrs and <80yrs
- Meet ARDS Berlin definition
- With mechanical ventilation
Key exclusion criteria (2 listed)
- have chronic pulmonary disease
- have use heparin or low molecular heparin or chondroitin sulfuric acid
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 |
|---|---|---|
| Glycocalyx measurement，respiratory mechanics measurementELASA measure glycocalyx, measure plateau pressure, driving pressure | Diagnostic test | Mild ARDS, Moderate ARDS, Severe ARDS |
Primary outcome
28 days mortality from patients involved in the study
Time frame: 28 days
28 days mortality from patients involved in the study
2 secondary outcomes
CT and syndecan-1 to evaluate pulmonary fibrosis
Time frame: 1mon, 3mon and 6 month
pulmonary function test to evaluate pulmonary function
Time frame: 1mon, 3mon and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Chun C Pan, Dr principal investigator
Zhongda hospital, Southeast University, Jiangsu, China
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 ARDS, Human and Endothelial Dysfunction, run by Southeast University, China 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 3 inclusion and 2 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 26 Feb 2019. 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 Chun C Pan, Dr (+862583262550, panchun1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days mortality from patients involved in the study (time frame: 28 days). 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 26 Feb 2019.