Methods
Barrett’s esophagus, bleeding, esophagitis, dyspepsia
BLEEDING, PEPTIC ULCER BLEEDING, GASTROESOPHAGEAL REFLUX, GI BLEEDING, ESOPHAGITIS, ZOLLINGER-ELLISON SYNDROME
REVISE is a multicenter, randomized, stratified, concealed, blinded parallel group trial in patients ≥ 18 years old in the intensive care unit (ICU), designed in collaboration with the Canadian Critical Care Trials Group (CCCTG) [[Inclusion and exclusion criteria 1. Already received invasive mechanical ventilation ≥ 72 h during this hospital admission 2. Acid suppression for active GI bleeding or high-risk of bleeding (e.g., current bleeding, peptic ulcer bleeding within 8 weeks, recent severe esophagitis, Barrett’s esophagus, Zollinger-Ellison syndrome) [dyspepsia or gastroesophageal reflux is not an exclusion criterion] 3. Acid suppression in the ICU for > 1 daily dose equivalent of a PPI or H2RA 4. Dual antiplatelet therapy 5. Combined antiplatelet and therapeutic anticoagulation 6. Pantoprazole contraindication per local product information 7. Palliative care or anticipated withdrawal of advanced life support 8, Pregnancy 9. Previous enrolment in REVISE, or a related trial, or trial for which coenrolment is prohibited 10. Patient, proxy, or physician declinesThis table details the inclusion and exclusion criteria for the REVISE Trial. When notified by research staff or investigators about eligible patients, research pharmacists or other blinded study personnel use a password-protected website to access the automated central randomization program to ensure concealed 1:1 allocation, stratified by center and pre-hospital acid suppression (i.e., PPI or HResearch staff upload daily data from hospital charts to a secure web-based electronic data capture system (iDataFax, Seattle, Washington) including baseline data, study drug administration, daily data in ICU up to 90 days post randomization, relevant laboratory values, cointerventions, trial outcomes, reports for adjudication, duration of mechanical ventilation, ICU and hospital stay, and mortality. Patients discharged alive from hospital before 90 days are followed for 90 days to obtain vital status. Further details are reported elsewhere [[