title: Pantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study.
abstract: OBJECTIVE
  Pantoprazole is frequently administered to critically ill patients for prophylaxis against gastrointestinal bleeding. However, comparison to placebo has been inadequately evaluated, and pantoprazole has the potential to cause harm. Our objective was to evaluate benefit or harm associated with pantoprazole administration.
  
  
  METHODS
  Prospective randomized double-blind parallel-group study.
  
  
  METHODS
  University-affiliated mixed medical-surgical ICU.
  
  
  METHODS
  Mechanically ventilated critically ill patients suitable for enteral nutrition.
  
  
  METHODS
  We randomly assigned patients to receive either daily IV placebo or pantoprazole.
  
  
  RESULTS
  Major outcomes were clinically significant gastrointestinal bleeding, infective ventilator-associated complication or pneumonia, and Clostridium difficile infection; minor outcomes included overt bleeding, hemoglobin concentration profiles, and mortality. None of the 214 patients randomized had an episode of clinically significant gastrointestinal bleeding, three patients met the criteria for either an infective ventilator-associated complication or pneumonia (placebo: 1 vs pantoprazole: 2), and one patient was diagnosed with Clostridium difficile infection (0 vs 1). Administration of pantoprazole was not associated with any difference in rates of overt bleeding (6 vs 3; p = 0.50) or daily hemoglobin concentrations when adjusted for transfusion rates of packed red cells (p = 0.66). Mortality was similar between groups (log-rank p = 0.33: adjusted hazard ratio for pantoprazole: 1.68 [95% CI, 0.97-2.90]; p = 0.06).
  
  
  CONCLUSIONS
  We found no evidence of benefit or harm with the prophylactic administration of pantoprazole to mechanically ventilated critically ill patients anticipated to receive enteral nutrition. The practice of routine administration of acid-suppressive drugs to critically ill patients for stress ulcer prophylaxis warrants further evaluation.
authors.affiliation: 1Discipline of Acute Care Medicine, the University of Adelaide, Adelaide, SA, Australia.2Department of Critical Care Services, Royal Adelaide Hospital, Adelaide, SA, Australia.3National Health and Medical Research Council of Australia Centre for Research Excellence in Nutritional Physiology and Outcomes, Adelaide, SA, Australia.4Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, SA, Australia.5Discipline of Medicine, the University of Adelaide, Adelaide, SA, Australia.
authors.forename: Shane P
authors.initials: SP
authors.lastname: Selvanderan
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Summers
authors.forename: Mark E
authors.initials: ME
authors.lastname: Finnis
authors.forename: Mark P
authors.initials: MP
authors.lastname: Plummer
authors.forename: Yasmine
authors.initials: Y
authors.lastname: Ali Abdelhamid
authors.forename: Michael B
authors.initials: MB
authors.lastname: Anderson
authors.forename: Marianne J
authors.initials: MJ
authors.lastname: Chapman
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Rayner
authors.forename: Adam M
authors.initials: AM
authors.lastname: Deane
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003015:Clostridium Infections / Q000453:epidemiology*; D004311:Double-Blind Method; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control*; D006785:Hospitals, University; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D053717:Pneumonia, Ventilator-Associated / Q000453:epidemiology*; D011446:Prospective Studies
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000077402:Pantoprazole