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Title: A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study): study protocol.
Authors: Young, Paul J;Bagshaw, Sean M;Forbes, Andrew;Nichol, Alistair;Wright, Stephen E;Bellomo, Rinaldo;Bailey, Michael J;Beasley, Richard W;Eastwood, Glenn M;Festa, Marino;Gattas, David;van Haren, Frank;Litton, Edward;Mouncey, Paul R;Navarra, Leanlove;Pilcher, David;Mackle, Diane M;McArthur, Colin J;McGuinness, Shay P;Saxena, Manoj K;Webb, Steve;Rowan, Kathryn M
Affiliation: Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand
Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada
Biostatistics Unit, Department of Epidemiology and Preventive Medicine at Monash University, Melbourne, Vic, Australia
Department of Perioperative and Critical Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom
Intensive Care Unit, Austin Health, Heidelberg, Victoria, Australia
Intensive Care Unit, Children's Hospital at Westmead, Sydney, NSW, Australia
Intensive Care Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia
Intensive Care Unit, Canberra Hospital, Canberra, ACT, Australia
Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, Australia
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia
Medical Research Institute of New Zealand, Wellington, New Zealand
The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia
Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, United Kingdom
Issue Date: Sep-2018
Citation: Critical Care and Resuscitation 2018; 20(3): 182-189
Abstract: The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. To describe the study protocol and statistical analysis plan for the Proton Pump Inhibitors versus Histamine-2 Receptor Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC) study. Protocol for a prospective, multicentre, randomised, open-label, cluster crossover, registry-embedded trial to be conducted in 50 ICUs in Australia, Canada, Ireland, New Zealand and the United Kingdom. The PEPTIC study will compare two approaches to stress ulcer prophylaxis in mechanically ventilated adults implemented at the level of the ICU. One approach is to use PPIs as the default therapy and the other approach is to use H2RBs as the default therapy when stress ulcer prophylaxis is prescribed. Each ICU, by random allocation, will use one approach for 6 months and will then switch to the opposite approach for the next 6 months. The PEPTIC study began recruitment in August 2016 and will complete recruitment in January 2019. The primary end point will be in-hospital mortality. Secondary outcomes include clinically significant upper gastrointestinal bleeding, Clostridium difficile infection, ICU length of stay and hospital length of stay. The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent. Australian and New Zealand Clinical Trials Registry (ANZCTRN 12616000481471).
ORCID: 0000-0002-1650-8939
PubMed URL: 30153780
ISSN: 1441-2772
Type: Journal Article
Subjects: Stomach Ulcer/prevention & control
Intensive Care Units
Proton Pump Inhibitors/therapeutic use
Histamine H2 Antagonists/therapeutic use
Appears in Collections:Journal articles

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