Re-Evaluating the Inhibition of Stress Erosions: Withholding Gastrointestinal Bleeding Prophylaxis In the ICU (REVISE): A Pilot Randomized Trial
CCCF ePoster library. Alhazzani W. Nov 2, 2016; 150999; 117
Waleed Alhazzani
Waleed Alhazzani
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Topic: Clinical Trial

Re-Evaluating the Inhibition of Stress Erosions: Withholding Gastrointestinal Bleeding Prophylaxis In the ICU (REVISE): A Pilot Randomized Trial

Waleed Alhazzani1,2, John C. Marshall3, Francois Lauzier4, John Muscedere5, Richard Hall6, Mohammed Alshahrani7, Shane W. English8, Tim Karachi1, Bram Rochwerg1, Geeta Mehta9, Lehana Thabane2,10, Yaseen M. Arabi11, Adam M. Deane12, Nicole Zytaruk2, Shelley Anderson-White2, Lois Saunders2, France Clarke2, Diane Heel-Ansdell2, Gordon Guyatt1,2, Deborah Cook1,2 on behalf of the Canadian Critical Care Trials Group

1 Department of Medicine, McMaster University, Hamilton, Canada
2 Department of Epidemiolgy and Biostatistics, McMaster University, Hamilton, Canada
3 Department of Surgery and Interdepartmental Division of Critical Care, University of Toronto, Toronto, Canada
4 Departments of Medicine, Anesthesiology & Critical Care, Université Laval, Quebec City, Canada
5 Department of Critical Care, Queens University, Kingston, Canada
6 Departments of Anesthesia, Pain Management and Perioperative Medicine and Critical Care Medicine, Dalhousie University, Halifax, Canada
7 Department of Critical Care, University of Dammam, Dammam, Saudi Arabia
8 Department of Medicine (Critical Care), University of Ottawa, Canada
9 Dept. of Medicine, University of Toronto, Toronto, Canada
10 Biostatistics Unit, St Joseph’s Healthcare Hamilton, Hamilton, Canada 
11Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia
12 Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia

Grant acknowledgements:
Funding: REVISE Pilot Trial is funded by Research Grants awarded by Physicians Services Incorporated of Ontario, Dammam University Research Funds, Capital Health Authority Research in Halifax, and the Royal Adelaide Hospital Project Committee.Waleed Alhazzani holds a McMaster University Department of Medicine Internal Career Research Award. Francois Lauzier is a recipient of a research career award from the Fonds de la recherche du Québec-Santé. Deborah Cook is a Canada Research Chair of the Canadian Institutes for Health Research.


Introduction: Proton pump inhibitors (PPIs) are widely used for stress ulcer prophylaxis in the intensive care unit (ICU). An overall decrease in the incidence of upper gastrointestinal (GI) bleeding and the presumed association between Clostridium difficile, ventilator associated pneumonia (VAP) and PPIs have raised questions about their use. To determine the feasibility of undertaking a larger trial to investigate the efficacy and safety of withholding intravenous PPIs, we conducted the REVISE Pilot Trial.
Methods:  We used a web-based system to randomize (1:1 ratio) adult critically ill patients expected to be mechanically ventilated for ≥48 hours to receive either 40 mg of intravenous (IV) pantoprazole once daily or to withhold prophylaxis and administer an identical IV placebo, while they were mechanically ventilated. We excluded patients if they had acute or recent GI bleeding, used dual antiplatelet agents, had a medical condition requiring PPI treatment, or if they had already received more than one daily-dose-equivalent of acid suppressive therapy in the ICU. Patients, families, clinicians, research staff, outcome adjudicators, and the statistician were blinded. Feasibility outcomes were: 1) Recruitment of at least 2 patients per centre per month; 2) Consent rate (≥70% of those approached successfully consent for enrolment); 3) Protocol adherence (administration of ≥ 80% of prescribed doses). Clinical outcomes included clinically important upper GI bleeding, Clostridium difficile infection, VAP, ICU and hospital length of stay, and mortality.
Results: We randomized 91 patients from nine centers in Canada, Saudi Arabia, and Australia; 49 to pantoprazole group and 42 to placebo group. The two groups had similar baseline characteristics. All feasibility goals were met: 1) the average recruitment rate was 2.6 patients/month; 2) the average consent rate was 77.8%; and 3) protocol adherence was 97.7%. Clinically important upper GI bleeding developed in 3/49 (6.1%) patients in pantoprazole group and 2/42 (4.8%) in placebo group. Clostridium difficile was identified in 2/49 (4.1%) patients in the pantoprazole group, and 1/42 (2.4%) patients in the placebo group. The median ICU length of stay was 12 days (interquartile range [IQR] 8 – 23) in pantoprazole group and 8.5 days (IQR 6 – 18) in placebo group. Hospital mortality was similar in both groups (17/48 [35.4%] vs. 13/42 [31%]; respectively).

Conclusions: The results of the international REVISE Pilot Trial support the feasibility of a larger trial to inform practice. Although the sample size of this Pilot Trial was small, there was no alarming increase in clinically important bleeding rates, which further support the conduct of larger trial.

Trial Registration: NCT02290327


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