REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol

Simple item page
dc.contributor.authorDeane, A.M.
dc.contributor.authorAlhazzani, W.
dc.contributor.authorGuyatt, G.
dc.contributor.authorFinfer, S.
dc.contributor.authorMarshall, J.C.
dc.contributor.authorMyburgh, J.
dc.contributor.authorZytaruk, N.
dc.contributor.authorHardie, M.
dc.contributor.authorSaunders, L.
dc.contributor.authorKnowles, S.
dc.contributor.authorLauzier, F.
dc.contributor.authorChapman, M.J.
dc.contributor.authorEnglish, S.
dc.contributor.authorMuscedere, J.
dc.contributor.authorArabi, Y.
dc.contributor.authorOstermann, M.
dc.contributor.authorVenkatesh, B.
dc.contributor.authorYoung, P.
dc.contributor.authorThabane, L.
dc.contributor.authorBillot, L.
dc.contributor.authoret al.
dc.date.issued2023
dc.description.abstractIntroduction: The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE. Methods and analysis: REVISE is an international, randomised, concealed, stratified, blinded parallelgroup individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.
dc.description.statementofresponsibilityAdam M Deane ... Marianne J Chapman ... Alexis Poole ... et al.
dc.identifier.citationBMJ Open, 2023; 13(11):1-11
dc.identifier.doi10.1136/bmjopen-2023-075588
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidDeane, A.M. [0000-0002-7620-5577]
dc.identifier.orcidChapman, M.J. [0000-0003-0710-3283]
dc.identifier.orcidPoole, A. [0000-0002-3345-1356]
dc.identifier.urihttps://hdl.handle.net/2440/140297
dc.language.isoen
dc.publisherBMJ
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT1124675
dc.rights© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
dc.source.urihttp://dx.doi.org/10.1136/bmjopen-2023-075588
dc.subjectpantoprazole
dc.subjectupper gastrointestinal (GI) bleeding
dc.subject.meshHumans
dc.subject.meshGastrointestinal Hemorrhage
dc.subject.meshRespiration, Artificial
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshIntensive Care Units
dc.subject.meshPneumonia, Ventilator-Associated
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshProton Pump Inhibitors
dc.subject.meshPantoprazole
dc.titleREVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol
dc.typeJournal article
pubs.publication-statusPublished

Files

Collections

Medicine publications