Acute Lung InjuryNCT02083393
Changes of Dendritic Cells in Acute Lung Injury
An observational study of Acute Lung Injury, run by Southeast University, China at 1 site in China.
Trial summary
To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2014
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sepsis induced-ALI patients with mechanical ventilation including invasive aspergillosis
Who may be able to join
- Sepsis induced acute lung injury
Who cannot join
- Younger than 18-year-old
- Pregnancy
- Cancer or organ transplant
- Asthma
- COPD
- Heart Failure
Trial locations and contacts
1 site in 1 country.
About this study
To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia
Read the detailed description
Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.
- Conditions
- Acute Lung Injury
- Keywords
- dendritic cell
- Medical subject headings
- Acute Lung Injury
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 |
|---|---|---|
| Patients with acute lung injury | Patients with sepsis induced acute lung injury | |
| Postsurgery patients | Postsurgery patients without acute lung injury and sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: 28day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJun 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Haibo Qiu, Ph.D., Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083393
- Sponsor's protocol ID
- SoutheastUChina2011ZDllKY04
- Status last verified
- May 2015
- First submitted
- 28 Sep 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Dendritic Cells in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT02083393
- Acronym / sponsor ID
- SoutheastUChina2011ZDllKY04
- Conditions
- Acute Lung Injury
- Keywords
- dendritic cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2014 (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 observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia
Detailed description
Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute lung injury | – | –Patients with sepsis induced acute lung injury |
| Postsurgery patients | – | –Postsurgery patients without acute lung injury and sepsis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis induced-ALI patients with mechanical ventilation including invasive aspergillosis
Key inclusion criteria (1 listed)
- Sepsis induced acute lung injury
Key exclusion criteria (6 listed)
- Younger than 18-year-old
- Pregnancy
- Cancer or organ transplant
- Asthma
- COPD
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
28-day mortality
Time frame: 28day
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 27 May 2015.
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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.
Haibo Qiu, Ph.D. principal investigator
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 Acute Lung Injury, 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 1 inclusion and 6 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 27 May 2015. 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?
28-day mortality (time frame: 28day). 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 27 May 2015.