Doctors and nurses working in intensive care are constantly searching for new ways to help people that become critically ill. Based on results from other studies, the BALTI-2 study was set up to investigate whether salbutamol (a widely used drug) would improve the health of patients with acute respiratory distress syndrome (ARDS), a serious lung condition which affects critically ill patients.
The primary objective of the study was to assess whether an intravenous infusion of salbutamol given at 15 µg (kg ideal body weight)-1 hour-1 for up to seven days reduced 28 day all-cause mortality in patients with Acute Respiratory Distress Syndrome (ARDS) compared with a placebo (0.9% sodium chloride) infusion.
The secondary objectives of the trial were:
- to evaluate the effects of IV salbutamol on mortality in ICU, mortality in hospital, ventilator-free days, organ failure-free days, length of ICU and hospital stay, mortality up to 12 months after randomisation, and health related quality of life six and 12 months after randomisation
- to evaluate the safety of IV salbutamol for ARDS patients
- to evaluate the cost-effectiveness of IV salbutamol for patients with ARDS
- to explore whether the effects of salbutamol vary between patients of different age, initial disease severity, mortality risk at ICU admission, and ARDS aetiology.
Summary of results
A total of 326 patients took part in the BALTI-2 study which took place in 46 intensive care units throughout the UK. Recruitment to this study ran from November 2006 to March 2010, and one-year follow-up was completed in March 2011. The study found that salbutamol was unlikely to be beneficial and may make outcomes worse, and therefore it is recommended that this drug is not used to treat Intensive Care patients who have acute respiratory distress syndrome.
Perkins GD, Gates S, Lamb SE, McCabe C, Young D, Gao F. Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: A randomised, double-blind, placebo controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome. Trials, 2011; 12: 113.
Smith FG, Perkins GD, Gates S, Young D, McAuley DF, Tunnicliffe W, Khan Z, Lamb SE, for the BALTI-2 study investigators. Effect of intravenous B2 agonist treatment on clinical outcomes in acute respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled trial. Lancet, 2012; 379: 229-235.
- Prof Fang Gao Clinical Professor in Anaesthesia, Critical Care & Pain
- Dr Gavin Perkins Professor in Critical Care & Resuscitation
- Prof Sallie Lamb Professor of Rehabilitation & Director of CTU
- Dr Simon Gates Professor in Clinical Trials
- Dr Sarah Duggan Clinical Trials Unit Manager