title: Re-evaluating the Inhibition of Stress Erosions (REVISE): a protocol for pilot randomized controlled trial.
abstract: BACKGROUND
  Clinicians routinely administer stress ulcer prophylaxis to mechanically ventilated patients in the intensive care unit (ICU), most commonly prescribing proton pump inhibitors (PPIs). However, the incidence of gastrointestinal (GI) bleeding from stress ulceration is low and recent observational studies suggest these agents may increase infections. Therefore, a large randomized clinical trial (RCT) is needed to inform modern practice. The aim of this multicenter pilot trial is to determine the feasibility of performing a large RCT to investigate the efficacy and safety of withholding intravenous pantoprazole.
  
  
  METHODS
  We will include adult critically ill patients who have an anticipated duration of ventilation of >=48 hours. We will exclude patients with acute or recent GI bleeding, pregnancy, dual antiplatelet therapy, poor prognosis or intent to withdraw life support, or previous enrolment in this or a confounding trial. Following informed consent, patients will be randomized to receive the intervention of placebo (0.9% NaCl) or intravenous pantoprazole 40 mg daily. Patients, families, clinicians, data collectors, adjudicators of outcome and statisticians will be blind to allocation. The three primary feasibility outcomes are the informed consent rate, recruitment rate, and protocol adherence. Clinical outcomes include clinically important upper GI bleeding, ventilator-associated pneumonia (VAP), Clostridium difficile infection, length of stay and mortality in ICU and hospital.
  This study has been approved by Health Canada, and research ethics board (REB) at each of the participating centers.
  
  
  BACKGROUND
  This trial was registered on 31 October 2014. The trial registration number is NCT02290327.
  
  
  BACKGROUND
  REVISE Pilot Trial is funded by Research Grant awarded by Physicians Services Incorporated, Dammam University Research Funds, Capital Health Authority Research Award Halifax, and Royal Adelaide Hospital Project Committee Grant.
authors.affiliation: Dr. Waleed Alhazzani, Critical Care Medicine, McMaster University,, 50 Charlton Avenue East,, Hamilton, Ontario,, L8N 4A6, Canada, T: +1905-522-1155 ext 32800, F: +1905-521-6068 waleed.al-hazzani@medportal.ca, ORCID: http://orcid.org/0000-0001-8076-9626.
authors.forename: Waleed
authors.initials: W
authors.lastname: Alhazzani
authors.forename: Gordon
authors.initials: G
authors.lastname: Guyatt
authors.forename: John C
authors.initials: JC
authors.lastname: Marshall
authors.forename: Richard
authors.initials: R
authors.lastname: Hall
authors.forename: John
authors.initials: J
authors.lastname: Muscedere
authors.forename: Francois
authors.initials: F
authors.lastname: Lauzier
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.forename: Mohammed
authors.initials: M
authors.lastname: Alshahrani
authors.forename: Shane W
authors.initials: SW
authors.lastname: English
authors.forename: Yaseen M
authors.initials: YM
authors.lastname: Arabi
authors.forename: Adam M
authors.initials: AM
authors.lastname: Deane
authors.forename: Tim
authors.initials: T
authors.lastname: Karachi
authors.forename: Bram
authors.initials: B
authors.lastname: Rochwerg
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
authors.forename: Nick
authors.initials: N
authors.lastname: Daneman
authors.forename: Nicole
authors.initials: N
authors.lastname: Zytaruk
authors.forename: Diane
authors.initials: D
authors.lastname: Heel-Ansdell
authors.forename: Deborah
authors.initials: D
authors.lastname: Cook
authors.forename: On Behalf
authors.initials: OB
authors.lastname: Of
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D010437:Peptic Ulcer / Q000209:etiology / Q000517:prevention & control*; D010438:Peptic Ulcer Hemorrhage / Q000209:etiology / Q000517:prevention & control; D010865:Pilot Projects; D012121:Respiration, Artificial / Q000009:adverse effects; D013315:Stress, Psychological / Q000209:etiology / Q000517:prevention & control*; D028761:Withholding Treatment
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D000077402:Pantoprazole