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dc.contributor.authorCasarin, Annalisa
dc.contributor.authorMcAuley, D.F
dc.contributor.authorAlce, T.M.
dc.contributor.authorZhao, Xiao B
dc.contributor.authorEly, E.W.
dc.contributor.authorJackson, J.C
dc.contributor.authorMcDowell, C
dc.contributor.authorAgus, A
dc.contributor.authorMurphy, L
dc.contributor.authorPage, Valerie J
dc.date.accessioned2018-02-05T17:37:40Z
dc.date.available2018-02-05T17:37:40Z
dc.date.issued2015-05-16
dc.identifier.citationCasarin , A , McAuley , D F , Alce , T M , Zhao , X B , Ely , E W , Jackson , J C , McDowell , C , Agus , A , Murphy , L & Page , V J 2015 , ' Evaluating early administration of the hydroxymethylglutaryl-CoA reductase inhibitor simvastatin in the prevention and treatment of delirium in critically ill ventilated patients (MoDUS trial): Study protocol for a randomized controlled trial ' , Trials , vol. 16 , no. 218 . https://doi.org/10.1186/s13063-015-0731-0
dc.identifier.issn1745-6215
dc.identifier.otherPURE: 13263452
dc.identifier.otherPURE UUID: 2946003b-33b2-41e2-8bc6-0339ed2f6aeb
dc.identifier.otherScopus: 84929414487
dc.identifier.urihttp://hdl.handle.net/2299/19728
dc.descriptionThis article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.description.abstractAbstract Background The incidence of delirium in ventilated patients is estimated at up to 82%, and it is associated with longer intensive care and hospital stays, and long-term cognitive impairment and mortality. The pathophysiology of delirium has been linked with inflammation and neuronal apoptosis. Simvastatin has pleiotropic properties; it penetrates the brain and, as well as reducing cholesterol, reduces inflammation when used at clinically relevant doses over the short term. This is a single centre randomised, controlled trial which aims to test the hypothesis that treatment with simvastatin will modify delirium incidence and outcomes. Methods/Design The ongoing study will include 142 adults admitted to the Watford General Hospital Intensive Care Unit who require mechanical ventilation in the first 72 hours of admission. The primary outcome is the number of delirium- and coma-free days in the first 14 days. Secondary outcomes include incidence of delirium, delirium- and coma-free days in the first 28 days, days in delirium and in coma at 14 and 28 days, number of ventilator-free days at 28 days, length of critical care and hospital stay, mortality, cognitive decline and healthcare resource use. Informed consent will be taken from patient’s consultee before randomisation to receive either simvastatin (80 mg) or placebo once daily. Daily data will be recorded until day 28 after randomisation or until discharge from the ICU if sooner. Surviving patients will be followed up on at six months from discharge. Plasma and urine samples will be taken to investigate the biological effect of simvastatin on systemic markers of inflammation, as related to the number of delirium- and coma-free days, and the potential of cholinesterase activity and beta-amyloid as predictors of the risk of delirium and long-term cognitive impairment. Discussion This trial will test the efficacy of simvastatin on reducing delirium in the critically ill. If patients receiving the statin show a reduced number of days in delirium compared with the placebo group, the inflammatory theory implicated in the pathogenesis of delirium will be strengthened. Trial registration The trial was registered with the International Standard Randomised Controlled Trial Registry (ISRCTN89079989) on 26 March 2013.en
dc.format.extent11
dc.language.isoeng
dc.relation.ispartofTrials
dc.rightsOpen
dc.subjectdelirium prevention
dc.subjectcognitive impairment
dc.subjectstatis
dc.subjectbeta-amyloid
dc.titleEvaluating early administration of the hydroxymethylglutaryl-CoA reductase inhibitor simvastatin in the prevention and treatment of delirium in critically ill ventilated patients (MoDUS trial): Study protocol for a randomized controlled trialen
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.description.statusPeer reviewed
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Published version
dcterms.dateAccepted2015-05-16
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.1186/s13063-015-0731-0
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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