The beta-agonist lung injury trial (BALTI): a randomized placebo-controlled clinical trial

Abstract

Rationale: Experimental data suggest that manipulation of alveolar fluid clearance with beta-agonists can accelerate the resolution of alveolar edema and improve survival.

Objective: To determine if a sustained infusion of intravenous salbutamol (albuterol) would accelerate the resolution of alveolar edema in adult patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).

Methods: This was a single-center, double-blind, randomized controlled trial. Patients with ALI/ARDS were randomized to treatment with intravenous salbutamol (15 microg kg(-1) h(-1)) or placebo for 7 d. The primary endpoint was extravascular lung water measured by thermodilution (PiCCO) at Day 7.

Measurements and main results: Sixty-six patients were screened; of these, 40 met the inclusion criteria and were enrolled during 2001-2003. Patients in the salbutamol group had significantly lower lung water at Day 7 than the placebo group (9.2 +/- 6 vs. 13.2 +/- 3 ml kg(-1); 95% confidence interval difference, 0.2-8.3 ml kg(-1); p = 0.038). Plateau airway pressure was lower at Day 7 in the salbutamol group (23.9 +/- 3.8 cm H2O) versus placebo (29.5 +/- 7.2 cm H2O; p = 0.049). There was a trend toward lower Murray lung injury score at Day 7 in the salbutamol group (1.7 +/- 0.9) versus placebo (2.0 +/- 0.6; p = 0.2). Patients in the salbutamol group had a higher incidence of supraventricular arrhythmias (26 vs. 10%; p = 0.2).

Conclusion: Although further research is required to confirm the efficacy and safety of intravenous salbutamol in ALI/ARDS, this trial provides the first proof of principle that, in humans with ALI/ARDS, sustained treatment with intravenous beta-agonists reduces extravascular lung water.