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Published on: September 22, 2023
Withholding Pantoprazole for Stress Ulcer Prophylaxis in Critically Ill Patients: A Pilot Randomized Clinical Trial
Waleed Alhazzani1, Gordon Guyatt, Mohammed Alshahrani
11Department of Medicine, McMaster University, Hamilton, ON, Canada.2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.3Department of Critical Care, University of Dammam, Dammam, Saudi Arabia.4Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.5Department of Surgery and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.6Departments of Anesthesia, Pain Management and Perioperative Medicine and Critical Care Medicine, Dalhousie University, Halifax, NS, Canada.7Department of Critical Care, Queens University, Kingston, ON, Canada.8Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada.9Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.10Departments of Medicine, Anesthesiology and Critical Care, Université Laval, Quebec City, QC, Canada.11Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.12Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.13The George Institute for Global Health and Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.14Department of Medicine, University of Toronto, Toronto, ON, Canada.15Department of Internal Medicine, College of Medicine and Health Sciences, UAE University, Al Ain, United Arab Emirates.
Introduction:
A decreased frequency of upper gastrointestinal bleeding and a possible association of proton pump inhibitor use with Clostridium difficile and ventilator-associated pneumonia have raised concerns recently. The Reevaluating the Inhibition of Stress Erosions Pilot Trial determined the feasibility of undertaking a larger trial investigating the efficacy and safety of withholding proton pump inhibitors in critically ill patients.
Methods:
In 10 ICUs, we randomized adult ICU patients anticipated to be mechanically ventilated for greater than or equal to 48 hours to receive 40 mg of IV pantoprazole daily or placebo. We excluded patients who had acute or recent gastrointestinal bleed, used dual antiplatelet agents, had a medical condition requiring proton pump inhibitor treatment, or had already received more than one dose of acid suppression daily. Patients, families, clinicians, and research staff were blinded. We conducted a systematic review and meta-analysis of similar trials.
Main Results:
Ninety-one patients (49 pantoprazole and 42 placebo) from 10 centers in Canada, Saudi Arabia, and Australia were enrolled. All feasibility goals were met: 1) recruitment rate was 2.6 patients per month; 2) consent rate was 77.8%; and 3) protocol adherence was 97.7%. Upper gastrointestinal bleeding developed in 6.1% of patients in the pantoprazole group and 4.8% in the placebo group (p = 1.0). Ventilator-associated pneumonia developed in 20.4% of patients in the pantoprazole group and 14.3% in the placebo group (p = 0.58). C. difficile was identified in 4.1% pantoprazole patients and in 2.4% placebo patients (p = 1.0). We meta-analyzed five trials (604 patients) of proton pump inhibitors versus placebo; there was no statistically significant difference in the risk of upper gastrointestinal bleeding, infections, or mortality.
Conclusions:
Our results support the feasibility of a larger trial to evaluate the safety of withholding stress ulcer prophylaxis. Although the results are imprecise, there was no alarming increase in the risk of upper gastrointestinal bleeding; the effect of proton pump inhibitors on ventilator-associated pneumonia and C. difficile remain unclear.
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