ARrest RESpiraTory Failure From PNEUMONIA (ARREST)
Pneumonia, Hypoxemia, Acute Respiratory Failure
About this trial
This is an interventional treatment trial for Pneumonia
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older with
Severe Pneumonia defined as hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan AND evidence of systemic inflammation (temperature < 35◦C or > 38◦C OR WBC > or < upper or lower limits for site OR procalcitonin > 0.5 mcg/L), OR known current immunosuppression preventing inflammatory response.
AND
- Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 < 92% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or non-invasive ventilation regardless of SpO2 at enrollment. Patients admitted with pneumonia but not meeting criteria for hypoxemia will be followed for up to 24 hours from ED admission to enrolling hospital to assess for development of qualifying hypoxemia.
Exclusion Criteria:
- Inability to obtain consent within 24 hours of presentation to enrolling hospital (up to 12 hours allowed at transferring ED for maximum of 36 hours from presentation)
Intubation (or impending intubation) prior to enrollment
a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded
- A condition requiring inhaled corticosteroids or beta-agonists (patients receiving inhaled beta-agonists in the ED without an established indication will be eligible if treating clinician is willing to discontinue subsequent treatments)
- Chronic systemic steroid therapy equivalent to >10 mg prednisone
- COVID-19 positive patients receiving > 6 mg dexamethasone (30 mg prednisone equivalent dose)
- Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except for stress dose steroids for septic shock
- Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
- Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization
- Contraindication or allergy to inhaled corticosteroids or beta-agonists
- Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved
- K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved
- Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)
- Pregnancy
- Incarcerated individual
- Physician refusal of consent to protocol
- Patient/surrogate refusal of consent to protocol
Sites / Locations
- University of Alabama-BirminghamRecruiting
- Mayo Clinic - ScottsdaleRecruiting
- University of Arizona - Main & South CampusRecruiting
- Stanford UniversityRecruiting
- University of Florida
- Mayo Clinic - JacksonvilleRecruiting
- Tulane University - Main & BUMCRecruiting
- University of MarylandRecruiting
- Johns Hopkins University - Main Campus & BayviewRecruiting
- Mayo Clinic - RochesterRecruiting
- New York University - Langone HealthRecruiting
- Temple UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Intervention
4 ml aerosolized 0.9% saline every 12 hours x 10 doses
aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses