Clarence Chant, PharmD, BCPS, FCSHP, FCCP; Karen E.A. Burns, MD, FRCPC, MSc (Epid)
Does IV salbutamol improve clinical outcomes in the early course of the acute respiratory distress syndrome (ARDS)?
Randomized placebo-controlled trial (β-Agonist Lung Injury Trial-2 [BALTI-2]). Current Controlled Trials ISRCTN38366450, and European Union Drug Regulating Authorities Clinical Trials EudraCT 2006-002647-86.
Blinded* (patients, clinicians, and investigators).
To death or discharge. The trial was stopped early because of increased mortality in the intervention group.
46 intensive care units in the UK.
326 patients ≥ 16 years of age (mean age 55 y, 65% men) who had new-onset (≤ 72 h) ARDS (PaO2/FIO2≤ 200 mm Hg, bilateral pulmonary infiltrates consistent with edema, and absence of left atrial hypertension) and were intubated or receiving mechanical ventilation. Exclusion criteria included pregnancy; current treatment with IV or continuous aerosolized β2-agonists or β-adrenergic antagonists; imminent withdrawal of medical treatment; and chronic liver disease.
IV salbutamol sulfate BP, 5 mL (15 µg salbutamol/kg ideal body weight/h) (n = 162), or placebo (0.9% sterile sodium chloride) (n = 164), for 7 days or less if clinically indicated.
Primary outcome was 28-day mortality. Secondary outcomes included ventilator-free days; organ failure–free days; and tachycardia, arrhythmia, and lactic acidosis leading to study drug cessation.
99% (intention-to-treat analysis).
The salbutamol group had higher rates of mortality at 28 days, and new-onset tachycardia, arrhythmia, and lactic acidosis leading to study drug cessation than the placebo group (Table). The salbutamol group had fewer ventilator-free days than the placebo group (8.5 vs 11.1, mean difference [MD] −2.7, 95% CI −4.7 to −0.7) and fewer organ failure–free days (16.2 vs 18.5, MD −2.3, CI −4.5 to −0.1).
In early acute respiratory distress syndrome, IV salbutamol increased mortality and adverse events (tachycardia, arrhythmia, and lactic acidosis), leading to study drug cessation. Salbutamol was also associated with fewer ventilator-free and organ failure–free days.
IV salbutamol vs placebo for the acute respiratory distress syndrome†
†Abbreviations defined in Glossary. RRI, NNH, and CI calculated from control event rates and risk ratios in article.
‡Leading to study drug cessation.
Chant C, Burns KE. IV salbutamol increased mortality in patients with the acute respiratory distress syndrome. Ann Intern Med. ;156:JC5–6. doi: 10.7326/0003-4819-156-10-201205150-02006
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Published: Ann Intern Med. 2012;156(10):JC5-6.
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