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:

  1. 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? 
  2. 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?