REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU

Patients who are critically ill in the Intensive Care Unit, especially those who need breathing machines, can develop ulcerations in the stomach that bleed. To prevent bleeding, most critically ill patients around the world receive a daily drug called pantoprazole that suppresses acid production. However, today, compared to decades ago, patients appear less likely to develop gastrointestinal bleeding, perhaps due to earlier feeding, modern medicine and better resuscitation. Studies of acid suppression are old and of poor quality such that their results are being questioned. There are also harms associated with acid suppressing drugs, including lung infections (pneumonia) and bowel infections (Clostridium difficile). Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the dangers of lung and bowel infections are actually more common and serious. The goal of this international study is to determine if, in critically ill patients needing breathing machines, pantoprazole is effective in preventing bleeding from stomach ulcers, or whether it increases the risk of pneumonia and Clostridium difficile, or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.