Status:

UNKNOWN

Macrophage Programing in Acute Lung Injury

Lead Sponsor:

National Jewish Health

Conditions:

Acute Respiratory Distress Syndrome

Eligibility:

All Genders

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, inju...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2023

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT03844893

Start Date

October 1 2019

End Date

March 1 2023

Last Update

August 22 2019

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