The REVISE Trial is testing the benefit and harms of using a common medication that reduces acid production in the stomach called pantoprazole. Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the esophagus, stomach or duodenum that can bleed. Therefore, many such patients receive a drug that suppresses acid production to decrease the risk of bleeding. However, nowadays, patients seem to very rarely develop bleeding compared to decades ago. This is believed to be due to modern medicine, better critical care resuscitation and earlier feeding. In addition, recent research suggests that the use of pantoprazole and other drugs that reduce acid levels in the stomach may increase the risk of more serious lung infections (pneumonia), bowel infections (Clostridium difficile), and possibly contribute to acute kidney injury, which are bigger problems today than bleeding. The quality of published research in this area is modest and it is difficult to tell if the pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems caused by these drugs.
The purpose of this trial is to determine if in mechanically ventilated patients in the ICU, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia), bowel infection (Clostridium difficile), or kidney injury, or whether pantoprazole has no effect at all. This large international study will provide important results that will inform the care of patients on breathing machines in the ICU.
Patients enrolled in this trial will be followed by the research team while in the ICU. They will receive either pantoprazole or a placebo, determined by chance. That is, there is a 50% chance of receiving the pantoprazole and a 50% chance of receiving a placebo (which is 0.9% normal saline, or inactive salt water). Patients allocated to receive the pantoprazole will be given 40 mg of pantoprazole intravenously once daily. Patients allocated to receive the placebo will be given an identical looking inactive fluid intravenously once daily. The first dose will be given as soon as possible.
This issue is being re-evaluated around the world in the REVISE Trial which is getting underway.