BALTI 2: The Beta-2 Agonist Lung Injury Trial 2

Acute Respiratory Distress Syndrome (ARDS) is a common and extremely serious type of respiratory failure among patients in intensive care units. Nearly half of the patients who suffer ARDS die, and many of the survivors have long-term health problems. A small-scale study suggested that intravenous salbutamol given for 7 days early in the course of ARDS may help more patients to survive. This project will determine whether this is correct, by comparing the results among over 1300 patients, half of whom (decided at random) will receive salbutamol and half of whom will receive an inactive solution.

BALTI 2 is a multicentre, randomised, double-blind, placebo-controlled trial to determine whether intravenous salbutamol infusion in critically ill adult patients with acute respiratory distress syndrome (ARDS) influences 28 day mortality. The setting will be adult Intensive Care Units (ICUs) within the National Health Service in the UK with the ability to provide full (Level 3) Intensive Care.

The BALTI 2 trial is an effectiveness study, where the allocation of salbutamol or placebo infusion is determined randomly, but all other treatment decisions are left to the clinicians managing the patient. 1344 patients will be randomised within 72 hours of the onset of ARDS, and and the primary outcome is mortality 28 days after randomisation. All patients will be followed up at 1 year to determine whether salbutamol treatment has any effect on the health of survivors over the subsequent year. An economic evaluation willl be conducted alongside the trial.