ARrest RESpiraTory Failure From PNEUMONIA (ARREST)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    600
  • sponsor
    Stanford University
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Updated on 4 October 2022
See if I qualify
pneumonia
procalcitonin
dyspnea
chest radiograph
respiratory failure
cough
shortness of breath
assisted ventilation

Summary

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.

Details
Condition Pneumonia, Hypoxemia, Acute Respiratory Failure, COVID-19 Pneumonia
Treatment inhaled placebo, Inhaled budesonide and formoterol
Clinical Study IdentifierNCT04193878
SponsorStanford University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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pneumonia
procalcitonin
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chest radiograph
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shortness of breath
assisted ventilation

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