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
Paul J Young, Sean M Bagshaw, Andrew Forbes, Alistair Nichol, Stephen E Wright, Rinaldo Bellomo, Michael J Bailey, Richard W Beasley, Glenn M Eastwood, Marino Festa, David Gattas, Frank van Haren, Edward Litton, Paul R Mouncey, Leanlove Navarra, David Pilcher, Diane M Mackie, Colin J McArthur, Shay P McGuinness, Manoj K Saxena Show all
CRITICAL CARE AND RESUSCITATION | AUSTRALASIAN MED PUBL CO LTD | Published : 2018
BACKGROUND: 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. OBJECTIVE: 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. DESIGN, SETTING AND PARTICIPANTS: 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. Th..View full abstract
The PEPTIC study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Irish Critical Care Trials Group, the Health Research Board Irish Critical Care Clinical Trial Network, and the Alberta Health Services Critical Care Strategic Clinical Network. The study is funded by the Health Research Council of New Zealand and the Health Research Board of Ireland. All analyses will be undertaken independent of the funding bodies. Sean Bagshaw was supported by a Canadian Research Chair in Critical Care Nephrology. Alistair Nichol was supported by a Health Research Board of Ireland Clinical Trial Network award. This research will be conducted during the tenure of a Health Research Council of New Zealand Clinical Practitioner Fellowship held by Paul Young. The Medical Research Institute of New Zealand is supported by Independent Research Organisation funding from the Health Research Council of New Zealand. For complete details on the participating investigators and institutions in this project, please see the online Appendix (available at cicm.org.au/Resources/Publications/Journal).