Macrophage Programing in Acute Lung Injury
1 other identifier
observational
56
0 countries
N/A
Brief Summary
The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedAugust 22, 2019
February 1, 2019
3.4 years
February 12, 2019
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluation and roles of macrophages during ARDS
Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated
10 days
Evaluation and roles of macrophages during ARDS
Evaluation of recruited alveolar macrophages will be isolated using FACS and subjected to RNA sequencing. Pro-inflammatory and pro-reparative modules will be assessed in the data set expression of transcription factors reported to drive macrophage polarization (HIF-1α, NF-kB, STAT-1, STAT-3, STAT-6, PPARγ, PU.1) will be assessed.
10 days
Interventions
Mini-BAL is a minimally invasive technique frequently used in the investigator's local intensive care units (ICUs) to obtain alveolar fluid samples from mechanically ventilated patients. This is typically done for microbial analysis.
Eligibility Criteria
The population to be studied are patients identified to have ARDS, admitted to the intensive care unit, and placed on a mechanical ventilator. The MICU at National Jewish-St Joseph Hospital will be the primary site for enrollment. Control subjects will be individuals on mechanical ventilation for non-pulmonary reasons (i.e. following surgery, sepsis without lung involvement). A total of 56 subjects will be enrolled. As described below (in Research Methods and Enrollment) a 2:1 ratio of ARDS to control subjects will be targeted.
You may qualify if:
- Written, informed consent (by surrogate if unconscious or if altered mental status)
- Admission to a Medical Intensive care unit
- Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
- Expected to remain mechanically ventilated for at least 48 h after the first study procedure.
You may not qualify if:
- Treatment with immunosuppressants in the prior 3 months (antineoplastic agents, tumor necrosis factor alpha antagonists, cyclosporine, methotrexate, azathioprine, or mycophenolate. Treatment with glucocorticoids for septic shock is acceptable).
- History of solid organ or bone marrow transplantation
- History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
- Human immunodeficiency virus positivity
- Severe or massive hemoptysis
- At significant risk for bleeding (INR \> 3 or PTT \> 3x normal)
- Presence of an advanced directive to withhold life-sustaining treatment
- Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition;
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 19, 2019
Study Start
October 1, 2019
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
August 22, 2019
Record last verified: 2019-02