Acute Respiratory Distress SyndromeNCT02967471
Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by The Third Affiliated Hospital of Southern Medical University.
Trial summary
Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have ARDS and admitted in hospital
Who may be able to join
- Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples Study Population：Patients who have ARDS and admitted in hospital Criteria：Inclusion Criteria:The Berlin definition of acute respiratory distress syndrome,ATS definition of severe pneumonia
Who cannot join
- age below 18 years,pregnancy,Expected survival under 24 hours
Trial locations and contacts
No sites are listed yet.
About this study
Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.
Read the detailed description
Background Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.
Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples
Study Population Patients who have ARDS and admitted in hospital
Primary Outcome Measures:
ILC2 and ILC3 number from peripheral blood of ARDS patients
Secondary Outcome Measures:
APACHE III score [ Time Frame: baseline, 1week, 2 weeks ] PaO2/FiO2 ratio[ Time Frame: baseline, 1week, 2 weeks ] Mortality or multi-organ failure [ Time Frame: 1 month ]
Groups:
- Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
- Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O
- Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O
- Healthy
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS
- 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 |
|---|---|---|
| ARDS group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ILC 3
innate lymphoid cells 3
Measured: 1 months after the onset
ILC 2
innate lymphoid cells 2
Measured: 1 months after the onset
Secondary outcomes (3)
APACHE III score
Measured: 1 months after the onset
PaO2/FiO2 ratio
Measured: 1 months after the onset
Mortality or multi-organ failure
Measured: 1 months after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startOct 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hui Peng, The Third Affiliated Hospital of Southern Medical University
- Investigators
- Jinhong Wang, M.D., Study chair, The Third Affiliated Hospital of Southern Medical UniversityHui Peng, M.M., Principal investigator, The Third Affiliated Hospital of Southern Medical UniversityHong Yang, M.D., Study director, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967471
- Sponsor's protocol ID
- ARDS-ILC001
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)
- ClinicalTrials.gov ID
- NCT02967471
- Acronym / sponsor ID
- ARDS-ILC001
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical UniversityOther government
- Study start
- Oct 2017
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- 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.
Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.
Detailed description
Background Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.
Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples
Study Population Patients who have ARDS and admitted in hospital
Primary Outcome Measures:
ILC2 and ILC3 number from peripheral blood of ARDS patients
Secondary Outcome Measures:
APACHE III score [ Time Frame: baseline, 1week, 2 weeks ] PaO2/FiO2 ratio[ Time Frame: baseline, 1week, 2 weeks ] Mortality or multi-organ failure [ Time Frame: 1 month ]
Groups:
- Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
- Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O
- Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O
- Healthy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have ARDS and admitted in hospital
Key inclusion criteria (1 listed)
- Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples Study Population：Patients who have ARDS and admitted in hospital Criteria：Inclusion Criteria:The Berlin definition of acute respiratory distress syndrome,ATS definition of severe pneumonia
Key exclusion criteria (1 listed)
- age below 18 years,pregnancy,Expected survival under 24 hours
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
ILC 3
Time frame: 1 months after the onset
innate lymphoid cells 3
ILC 2
Time frame: 1 months after the onset
innate lymphoid cells 2
3 secondary outcomes
APACHE III score
Time frame: 1 months after the onset
PaO2/FiO2 ratio
Time frame: 1 months after the onset
Mortality or multi-organ failure
Time frame: 1 months after the onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- 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.
Jinhong Wang, M.D. study chair
The Third Affiliated Hospital of Southern Medical University
Hui Peng, M.M. principal investigator
The Third Affiliated Hospital of Southern Medical University
Hong Yang, M.D. study director
The Third Affiliated Hospital of Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by The Third Affiliated Hospital of Southern Medical University.
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 1 inclusion and 1 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Jinhong Wang, M.D. (+86 13113319966, leechy911@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ILC 3 (time frame: 1 months after the onset). 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 21 Nov 2016.