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Alveolar Macrophage Programming Following Endotoxin Exposure

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National Jewish Health

Status

Enrolling

Conditions

ARDS, Human

Treatments

Other: bronchoscopy with intrabronchial administration of lipopolysaccharide

Study type

Interventional

Funder types

Other

Identifiers

NCT03859050
HS-3131

Details and patient eligibility

About

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).

Enrollment

25 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Written, informed consent
  2. Age 18-50

Exclusion criteria

  1. Current or recent illness (past 2 weeks)
  2. Presence or prior history of cardiac, pulmonary or systemic disease
  3. Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
  4. American Society of Anesthesiology (ASA) class 2 or greater
  5. Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
  6. 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
  7. Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
  8. Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
  9. Abnormal spirometry or electrocardiogram at time of screening
  10. Pregnant (based on urine pregnancy test) or breast feeding

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

LPS arm
Experimental group
Treatment:
Other: bronchoscopy with intrabronchial administration of lipopolysaccharide

Trial contacts and locations

1

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Central trial contact

Kara Mould

Data sourced from clinicaltrials.gov

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