GD Perkins, DF McAuley, DR Thickett & F Gao. The β-Agonist Lung Injury Trial (BALTI). Am J Respir Crit Care Med 2006; 173: 281–287
RHH Journal Club. December 1st, 2011. Dr Helen Findley
Full-text article (if available)
Does a sustained infusion of the intravenous β2-agonist salbutamol accelerate the resolution of pulmonary oedema in adult patients with ALI or ARDS?
Single centre. Double blind. Randomised Controlled Trial at Heartlands Hospital, Birmingham between 2001-3
Mechanically ventilated adults at Heartlands Hospital within 48 h of the onset ALI or ARDS (Consensus definition)
Block randomization to salbutamol or placebo (1:1) – 0.9% saline.
Infusions were started within 2 h of randomization and run at 15 mcg/kg/h for 7 d.
Highest tolerable dose without significant arrhythmias –pilot study.
Safety dose adjustment protocol for tachycardia/arrhythmias.
Reduction in extravascular lung water at day 7.
Powered to detect a 30% difference in EVLW between patient treatment and control groups with 80% power at a significance level of 0.05.
Murray Lung Injury Score at day 7; Pa02/Fi02 ratio; Plateau airway pressure; Ventilator free days in first 28 days; Survival at 28 days; Safety and tolerability: ECG, CVS variables, electrolytes and acid-base balance.
Did groups start with a similar prognosis?
Intervention arm was significantly older
Aetiology of lung injury different (more pneumonia in placebo arm)
Numbers involved: 40 patients enrolled and treated (66 eligible)
Investigators- one performed block randomisation but was involved in analysis (not data collection)
Clinicians –nursing staff prepared infusions
Intention to treat principle applied. 18/19 received intervention in salbutamol arm. 1 died before starting infusion.
Confounding factors considered
Follow up complete but high mortality during study period in both arms.
Patients in the salbutamol-treated group had significantly lower lung water at Day 7 than those in the placebo group.
No significant differences in:
Pa02:Fi02 ratio, SOFA score, Ventilator free days, 28 day mortality
“Trend” towards lower lung injury score – non significant.
Significant differences in day 7 plataeu airway pressures in salbutamol group (p=0.049)
Take home message/application of this research
- IV salbutamol may reduce EVLW in patients with ALI/ARDS but BALTI failed to demonstrate clinically relevant patient benefit (secondary outcomes). There are safety concerns re SVT and hypokalaemia.
- Update: BALTI -2 trial terminated early as IV salbutamol very unlikely to show any treatment advantages