ARrest RESpiraTory Failure From PNEUMONIA
ARrest RESpiraTory Failure From PNEUMONIA
This research study seeks to establish the effectiveness of a combination of an inhaled
 corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory
 failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
Inclusion Criteria:

 -  Severe Pneumonia defined as hospitalization for acute (< 7 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 < 35oC or >
 38oC 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 supplemental oxygen with SpO2 < 90% on room
 air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.

 and

 -  No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2
 infection.

 Exclusion Criteria:

 -  Inability to obtain consent within 24 hours of presentation to emergency room

 -  Intubation (or impending intubation) prior to enrollment (This does not include those
 patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation
 (NIV) prior to enrollment)

 -  A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic
 steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients
 receiving inhaled beta-agonists in the Emergency Department without an established
 indication if treating clinician is willing to discontinue subsequent treatments)

 -  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 known 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

 -  Patients with 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