BALTI – better curry than therapy for ARDS?

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?

Study design

Single centre. Double blind. Randomised Controlled Trial at Heartlands Hospital, Birmingham between 2001-3

Methodology

Population:

Mechanically ventilated adults at Heartlands Hospital within 48 h of the onset ALI or ARDS (Consensus definition)

Intervention/control

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.

Primary outcome:

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.

Secondary outcomes:

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.

Validity

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)

Randomisation concealed

Blinded

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.

Results

Primary outcome:

Patients in the salbutamol-treated group had significantly lower lung water at Day 7 than those in the placebo group.

Secondary outcomes:

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
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One thought on “BALTI – better curry than therapy for ARDS?

  1. Pingback: STH Breakfast Club: ARDS | STH Journal Club

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