NCT02290327.

Trial name or title	Re‐evaluating the inhibition of stress erosions: gastrointestinal bleeding prophylaxis In ICU (REVISE)
Methods	Quadruple blind parallel‐group randomised controlled study
Participants	Inclusion criteria Adults ≥ 18 years Anticipated invasive mechanical ventilation ≥ 48 hours, as determined by the intensivist Exclusion criteria Invasive mechanical ventilation > 72 hours before randomisation Must receive PPI owing to active bleeding or increased bleeding risk (e.g. patients with acute GI bleeding, recent severe oesophagitis, Zollinger‐Ellison syndrome, Barrett's oesophagus, peptic ulcer bleeding within 8 weeks (mild dyspepsia or mild gastro‐oesophageal reflux disease will not be excluded)) Receiving dual antiplatelet therapy aspirin and clopidogrel before randomisation Palliative care or decision to withdraw advanced life support (decision to forego cardiopulmonary resuscitation will not be excluded) Previous enrolment in this or a related study Pregnancy Physician, patient, or substitute decision‐maker (SDM) declines Two or more "daily doses" of prophylaxis with H2RA or PPI (1 day of a single PPI dose is not an exclusion criterion if once‐daily dosing of PPI prophylaxis was administered; 1 day of bid (twice‐daily) dosing of an H2RA is not an exclusion criterion if twice‐daily H2RA prophylaxis was administered; 1 day of 3 times daily dosing of an H2RA is not an exclusion criterion if thrice‐daily H2RA prophylaxis was administered)
Interventions	Intervention: pantoprazole 40 mg in 50 mL 0.9% normal saline intravenously once daily Control: placebo 50 mL of 0.9% normal saline intravenously once daily
Outcomes	Primary outcomes Consent rate [time frame: 12 months]. This will be calculated as the overall proportion of consented patients of those substitute decision‐makers (SDMs) approached (with 95% CI). A successful consent rate will be defined as ≥ 70% of SDMs approached to consent Recruitment rate [time frame: 12 months]. A successful recruitment rate will be defined as achieving enrolment of 60 patients, conventionally expressed as 2 patients per canter per month over 12 months Protocol adherence [time frame: 12 months ]. This will be calculated as doses of study drug administered as a proportion of doses prescribed and associated 95% confidence intervals. Successful adherence will be defined as ≥ 80% of prescribed drugs being administered Secondary outcomes Clinically important upper gastrointestinal bleeding [time frame: during ICU stay (expected average is 10 days)] Ventilator‐associated pneumonia [time frame: during ICU stay (expected average is 10 days)] Mortality [time frame: during ICU and hospital stay (expected average ICU stay is 10 days, expected average hospital stay is 30 days)] Clostridium difficile infection [time frame: during ICU stay (expected average ICU stay is 10 days)]
Starting date	May 2015
Contact information	‐
Notes	clinicaltrials.gov/ct2/show/record/NCT02290327