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Recruiting
I'm InterestedTrial ID: NCT01783821
LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)
Inclusion Criteria:
- Adult patients (age > 18)
- Admitted to the hospital through the emergency department (ED)
- High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or
equal to four)
Exclusion Criteria:
- Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days
prior to admission (history of asthma or COPD necessitating therapy)
- Chronic pulmonary disease requiring daytime oxygen supplementation therapy
- Systemic steroid treatment on admission or within 7 days prior to admission equivalent
to more than 5 mg of prednisone daily
- Inability to obtain consent within 12 hours of hospital presentation
- Acute lung injury prior to randomization
- Receiving mechanical ventilation before current hospital admission (patient who is
ventilator dependent)
- Presentation believed to be purely due to heart failure without other known risk
factors for ARDS
- Allergy or other contraindication to either budesonide and/or formoterol use
- Expected hospital stay and/or survival <48 hours or admission for comfort or hospice
care
- Patient, surrogate or physician not committed to full support (exception: a patient
will not be excluded if he/she would receive all supportive care except for attempts
at resuscitation from cardiac arrest)
- Previous enrollment in this trial.
- Co-enrollment with LIPS-A trial is not allowed.
- An active enrollment in other concomitant trial will be judged on case by case basis
by PIs of both trials.
- EKG and/or clinical presentation suggestive of acute coronary ischemia
- New onset cardiac arrhythmia
- Current atrial fibrillation with ventricular rate of >110/minute
- Persistent sinus tachycardia of >130/minute despite early goal directed therapy with
fluids, pressors, antibiotics and supplemental oxygen
- Pregnant patients
drug: Placebo
drug: Budesonide
drug: Formoterol
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rosemary Vojnik