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BALTI Prevention Study (Beta-Agonist Lung Injury Trial)
A multicentre randomised, double blind, placebo controlled trial to evaluate the impact of inhaled salmeterol on the development of postoperative acute lung injury/acute respiratory distress syndrome in patients undergoing oesophagectomy.
Oesophagectomy has a high incidence of postoperative acute lung injury/acute respiratory distress syndrome, and provides an excellent model for the study of therapies looking to treat the condition. Beta agonists have been shown in animal and human models to increase alveolar fluid clearance, and also to have a variety of anti-inflammatory effects. Both of these actions may have clinically significant benefits in the treatment of acute lung injury.
The BALTI Prevention study aims to recruit 216 patients undergoing oesphagectomy at a number of centres across central England, and administer inhaled 100mcg salmeterol/ identical placebo every 12 hours for a total of 72 hours perioperatively. The first dose will be given within 2 hours of the induction of anaesthesia.
The primary endpoint will be the development of clinically significant lung injury, and secondary outcomes will include survival at 28 and 90 days, the global severity of illness at admission to ITU, the severity of respiratory illness, the duration of ventilation and organ failure, and health related quality of life measured by questionnaire at 28 and 90 days.