Re-Evaluating the Inhibition of Stress Erosions and prophylaxis against gastrointestinal bleeding in the critically ill (REVISE)
A prospective, multicentre, parallel group, concealed, blinded, randomised controlled trial in critically ill mechanically-ventilated adults. The aim is:
- To determine whether the administration of placebo (daily administration of 10 ml 0.9% saline IV) is non-inferior to standard practice (daily administration of pantoprazole 40 mg IV) when judged by the incidence of clinically important gastrointestinal (GI) bleeding?
- To determine whether the administration of placebo (daily administration of 10 ml 0.9% saline IV) is superior to standard practice (daily administration of pantoprazole 40 mg IV) as it results in a reduction in net harm by reducing the incidence of serious infectious complications (ventilator-associated pneumonia and Clostridium difficile infection) and therefore "downstream" harms when measured as duration of mechanical ventilation, intensive care unit (ICU) and hospital length of stay, and 90-day mortality?
