The β-Agonist Lung Injury Trial (BALTI): A Randomized Placebo-controlled Clinical Trial

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Abstract

Rationale:

Experimental data suggest that manipulation of alveolar fluid clearance with β-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 μg 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 β-agonists reduces extravascular lung water.

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