Acute Lung InjuryNCT02693912
Changes in Alveolar Macrophage Function During Acute Lung Injury
An observational study of Acute Lung Injury, run by West China Hospital.
Trial summary
In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 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: ALI and acute respiratory distress syndrome (ARDS) are characterized by an increased permeability of the alveolar-capillary barrier resulting in lung edema with protein-rich fluid, thus resulting in impairment of arterial oxygenation. ALI/ARDS is defined as a lung disease with acute onset, noncardiac, diffuse bilateral pulmonary infiltrates and a paO2/FiO2 ≤ 300 for ALI or a paO2/FiO2 ≤ 200 for ARDS. The ageadjusted incidence of ALI/ARDS is estimated with 86.2 per 100,000 person-years. Despite all innovations in intensive care medicine, the mortality of ARDS remains up to 40%.
Who may be able to join
- Patients in ICU with diagnosed ALI under mechanical ventilation
Who cannot join
- Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis
Trial locations and contacts
No sites are listed yet.
Chunling Jiang contact
About this study
In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.
Read the detailed description
Alveolar macrophages are tissue-resident or recruited cells with key functions in recognition of pathogens, initiation of host defensive ang protective inflammation,and in clearance of pathogens from the airways. However, macrophages are also responsible for efficient clearance of apoptotic neutrophils, termed efferocytosis, which is a prerequisite for the timely resolution of inflammation. In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.
- Conditions
- Acute Lung Injury
- Being tested
- Bronchoscopy
- Keywords
- efferocytosis, macrophage
- 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.
BronchoscopyProcedure or surgery
Bronchoscopy will be implemented under sedation in both groups.
| Study group | Role | What they receive |
|---|---|---|
| acute lung injury | Patients with a diagnosis of acute lung injury (ALI) under mechanical ventilation.Patients will underwent bronchoscopy for bronchoalveolar lavage fluid. Receives: Procedure: Bronchoscopy | |
| control | Patient under mechanical ventilation without any lung diseases. Patients will underwent bronchoscopy for bronchoalveolar lavage fluid. Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar macrophages (AMs) phagocytic index
AMs will be collected and cultured in vitro. Apoptotic neutrophils will then be cocultured with AMs for 1 hour. To measure phagocytosis of apoptotic neutrophils, AMs were further processed and phagocytosed apoptotic neutrophils were detected by confocal fluorescence microscopy as described below under Cell staining and confocal microscopy. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100.
Measured: 7 days after admission
Secondary outcomes (1)
30 days mortality
Measured: 30 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
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.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Jin Liu, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693912
- Sponsor's protocol ID
- wch-150718
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan has been made to share data
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Alveolar Macrophage Function During Acute Lung Injury
- ClinicalTrials.gov ID
- NCT02693912
- Acronym / sponsor ID
- wch-150718
- Conditions
- Acute Lung Injury
- Keywords
- efferocytosis, macrophage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 29 Feb 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.
In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.
Detailed description
Alveolar macrophages are tissue-resident or recruited cells with key functions in recognition of pathogens, initiation of host defensive ang protective inflammation,and in clearance of pathogens from the airways. However, macrophages are also responsible for efficient clearance of apoptotic neutrophils, termed efferocytosis, which is a prerequisite for the timely resolution of inflammation. In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute lung injury | – | Procedure: BronchoscopyPatients with a diagnosis of acute lung injury (ALI) under mechanical ventilation.Patients will underwent bronchoscopy for bronchoalveolar lavage fluid. |
| control | – | Procedure: BronchoscopyPatient under mechanical ventilation without any lung diseases. Patients will underwent bronchoscopy for bronchoalveolar lavage fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALI and acute respiratory distress syndrome (ARDS) are characterized by an increased permeability of the alveolar-capillary barrier resulting in lung edema with protein-rich fluid, thus resulting in impairment of arterial oxygenation. ALI/ARDS is defined as a lung disease with acute onset, noncardiac, diffuse bilateral pulmonary infiltrates and a paO2/FiO2 ≤ 300 for ALI or a paO2/FiO2 ≤ 200 for ARDS. The ageadjusted incidence of ALI/ARDS is estimated with 86.2 per 100,000 person-years. Despite all innovations in intensive care medicine, the mortality of ARDS remains up to 40%.
Key inclusion criteria (1 listed)
- Patients in ICU with diagnosed ALI under mechanical ventilation
Key exclusion criteria (1 listed)
- Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis
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 |
|---|---|---|
| BronchoscopyBronchoscopy will be implemented under sedation in both groups. | Procedure or surgery | acute lung injury, control |
Primary outcome
alveolar macrophages (AMs) phagocytic index
Time frame: 7 days after admission
AMs will be collected and cultured in vitro. Apoptotic neutrophils will then be cocultured with AMs for 1 hour. To measure phagocytosis of apoptotic neutrophils, AMs were further processed and phagocytosed apoptotic neutrophils were detected by confocal fluorescence microscopy as described below under Cell staining and confocal microscopy. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100.
1 secondary outcome
30 days mortality
Time frame: 30 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Individual participant dataSharing planned: No. no plan has been made to share data
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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.
Chunling Jiang contact
Jin Liu study chair
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury, run by West China Hospital.
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 29 Feb 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 Chunling Jiang (jiang_chunling@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alveolar macrophages (AMs) phagocytic index (time frame: 7 days after admission). 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 29 Feb 2016.