Intensive Care MedicineNCT02958748
Change of Immune Cell of ARDS Patients：an Observational Study
An observational study of Intensive Care Medicine and ARDS, run by Southeast University, China.
Trial summary
To evaluate change of different immune cellsduring ARDS and its impact on prognosis. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Medicine, ARDS
- What is being tested?
- taking blood sample
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Diagnosis:ARDS(The Berlin definition），onset within 48hours Without past history which may impact immune function
Who may be able to join
- ①sign on the acknowledged
- ②Diagnosis with ARDS(The Berlin definition），onset within 48hours
Who cannot join
- ①diagnosis of hematological or immunological disease
- ②treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
About this study
To evaluate change of different immune cellsduring ARDS and its impact on prognosis.
- Conditions
- Intensive Care Medicine, ARDS
- Being tested
- taking blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Patients admitted to ICU with diagnosis of ARDS,which happened in 48hours. Receives: Other: taking blood sample | |
| Control | Heathy vonlunteers Receives: Other: taking blood sample |
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 posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care MedicineStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958748
- Sponsor's protocol ID
- 20161106
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Immune Cell of ARDS Patients：an Observational Study
- ClinicalTrials.gov ID
- NCT02958748
- Acronym / sponsor ID
- 20161106
- Conditions
- Intensive Care Medicine, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- First posted
- 8 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.
To evaluate change of different immune cellsduring ARDS and its impact on prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Other: taking blood samplePatients admitted to ICU with diagnosis of ARDS,which happened in 48hours. |
| Control | – | Other: taking blood sampleHeathy vonlunteers |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis:ARDS(The Berlin definition），onset within 48hours Without past history which may impact immune function
Key inclusion criteria (2 listed)
- ①sign on the acknowledged
- ②Diagnosis with ARDS(The Berlin definition），onset within 48hours
Key exclusion criteria (2 listed)
- ①diagnosis of hematological or immunological disease
- ②treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
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 |
|---|---|---|
| taking blood sample | Other | ARDS, Control |
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 8 Nov 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Medicine and ARDS, run by Southeast University, 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 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 8 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?
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?
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 8 Nov 2016.