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Empirical meropenem...
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Granholm, AndersCopenhagen University Hospital
(författare)
Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial : Protocol
Nummerbeteckningar
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LIBRIS-ID:oai:lup.lub.lu.se:6c1f380b-16e8-45c8-b548-141c8b1f1c73
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https://lup.lub.lu.se/record/6c1f380b-16e8-45c8-b548-141c8b1f1c73URI
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https://doi.org/10.1111/aas.14441DOI
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Språk:engelska
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Sammanfattning på:engelska
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Klassifikation
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Ämneskategori:art swepub-publicationtype
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Ämneskategori:ref swepub-contenttype
Anmärkningar
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Background: Piperacillin/tazobactam may be associated with less favourable outcomes than carbapenems in patients with severe bacterial infections, but the certainty of evidence is low. Methods: The Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial is an investigator-initiated, international, parallel-group, randomised, open-label, adaptive clinical trial with an integrated feasibility phase. We will randomise adult, critically ill patients with sepsis to empirical treatment with meropenem or piperacillin/tazobactam for up to 30 days. The primary outcome is 30-day all-cause mortality. The secondary outcomes are serious adverse reactions within 30 days; isolation precautions due to resistant bacteria within 30 days; days alive without life support and days alive and out of hospital within 30 and 90 days; 90- and 180-day all-cause mortality and 180-day health-related quality of life. EMPRESS will use Bayesian statistical models with weak to somewhat sceptical neutral priors. Adaptive analyses will be conducted after follow-up of the primary outcome for the first 400 participants concludes and after every 300 subsequent participants, with adaptive stopping for superiority/inferiority and practical equivalence (absolute risk difference <2.5%-points) and response-adaptive randomisation. The expected sample sizes in scenarios with no, small or large differences are 5189, 5859 and 2570 participants, with maximum 14,000 participants and ≥99% probability of conclusiveness across all scenarios. Conclusions: EMPRESS will compare the effects of empirical meropenem against piperacillin/tazobactam in adult, critically ill patients with sepsis. Due to the pragmatic, adaptive design with high probability of conclusiveness, the trial results are expected to directly inform clinical practice.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Munch, Marie WarrerCopenhagen University Hospital
(författare)
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Meier, NickCRIC - Collaboration for Research in Intensive Care,Copenhagen University Hospital
(författare)
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Sjövall, FredrikLund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Mitokondriell Medicin,Forskargrupper vid Lunds universitet,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Mitochondrial Medicine,Lund University Research Groups,Skåne University Hospital(Swepub:lu)expb-fsa
(författare)
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Helleberg, MarieCopenhagen University Hospital,University of Copenhagen
(författare)
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Hertz, Frederik BoëtiusUniversity of Copenhagen,Copenhagen University Hospital
(författare)
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Kaas-Hansen, Benjamin SkovCopenhagen University Hospital,University of Copenhagen
(författare)
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Thorsen-Meyer, Hans ChristianCopenhagen University Hospital
(författare)
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Andersen, Lars WiuffAarhus University,Aarhus University Hospital
(författare)
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Rasmussen, Bodil SteenAalborg University Hospital,Aalborg University
(författare)
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Andersen, Jakob SteenCopenhagen University Hospital
(författare)
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Albertsen, Trine Lynge
(författare)
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Kjær, Maj Brit NørregaardCopenhagen University Hospital
(författare)
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Jensen, Aksel Karl GeorgUniversity of Copenhagen
(författare)
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Lange, TheisUniversity of Copenhagen
(författare)
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Perner, AndersCopenhagen University Hospital,University of Copenhagen
(författare)
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Møller, Morten HylanderCopenhagen University Hospital,University of Copenhagen
(författare)
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Copenhagen University HospitalCRIC - Collaboration for Research in Intensive Care
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Acta Anaesthesiologica Scandinavica0001-5172
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Granholm, Anders
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Munch, Marie War ...
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Meier, Nick
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Sjövall, Fredrik
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Helleberg, Marie
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Hertz, Frederik ...
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Kaas-Hansen, Ben ...
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Thorsen-Meyer, H ...
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Andersen, Lars W ...
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Rasmussen, Bodil ...
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Andersen, Jakob ...
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Albertsen, Trine ...
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Kjær, Maj Brit N ...
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Jensen, Aksel Ka ...
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Lange, Theis
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Perner, Anders
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Møller, Morten H ...
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