Alveolar Macrophage Programming Following Endotoxin Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bronchoscopy with intrabronchial administration of lipopolysaccharide.
- Who it may be relevant to
- Registry conditions: ARDS, Human. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The histologic hallmarks of lung inflammation include 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).
Interventions
- Other bronchoscopy with intrabronchial administration of lipopolysaccharide
The PI will administer intrabronchial LPS into the lungs of healthy volunteers and then obtaining macrophages by bronchoalveolar lavage (BAL) 24, 48, 72, 96, or 120 hours later.
Primary outcome measures
- Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Written, informed consent
- Age 18-50
Exclusion criteria
- Current or recent illness (past 2 weeks)
- Presence or prior history of cardiac, pulmonary or systemic disease
- Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
- American Society of Anesthesiology (ASA) class 2 or greater
- Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
- Use of any inhaled substance, including tobacco, marijuana, e-cigarrettes, cocaine, methamphetamines, or toxic vapors in the past 3 months or greater than 10 pack-year smoking history
- Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
- Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
- Abnormal spirometry or electrocardiogram at time of screening
- Pregnant (based on urine pregnancy test) or breast feeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- National Jewish Health — Denver
Identifiers
NCT: NCT03859050 · HS-3131