- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693912
Changes in Alveolar Macrophage Function During Acute Lung Injury
February 26, 2016 updated by: Chunling Jiang, West China Hospital
In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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%.
Description
Inclusion Criteria:
- Patients in ICU with diagnosed ALI under mechanical ventilation
Exclusion Criteria:
- Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
acute lung injury
Patients with a diagnosis of acute lung injury (ALI) under mechanical ventilation.Patients will underwent bronchoscopy for bronchoalveolar lavage fluid.
|
Bronchoscopy will be implemented under sedation in both groups.
|
control
Patient under mechanical ventilation without any lung diseases.
Patients will underwent bronchoscopy for bronchoalveolar lavage fluid.
|
Bronchoscopy will be implemented under sedation in both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days after admission
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
30 days mortality
Time Frame: 30 days after admission
|
30 days after admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jin Liu, West China Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 26, 2016
First Posted (Estimate)
February 29, 2016
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
February 26, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wch-150718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
no plan has been made to share data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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