Multi-centre, cluster crossover, randomised trial comparing proton pump inhibitors (PPIs) with histamine-2 receptor blockers (H2RBs) for ulcer prophylaxis in mechanically ventilated ICU patients. The overall objective of this study is to establish the risk of in-hospital deathusing PPIs vs. H2RBs for routine ulcer prophylaxis in mechanically ventilated patients in the ICU. Cluster crossover trial using data from existing databases and registries.
Between 13 and 20 million patients are admitted to an ICU around the world each year. Of these patients, 18- 30% die during their ICU admission. Almost all of the patients who die in the ICU receive mechanical ventilation. Despite this tremendous mortality burden, no treatment has been proven to reduce mortality in a large-scale trial in a general population of critically ill patients who require mechanical ventilation.
Any non-paediatric ICU that routinely manages mechanically ventilated patients will potentially be eligible to participate in the study.
ICUs that are unable or unwilling to follow the trial protocol, or ICUs that are unable to capture the required study data from established databases (potential study centres will be required to demonstrate that they are able to obtain required data from existing data sources by participating in a retrospective cohort study using the study data points.