{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T10:52:10Z","timestamp":1788259930916,"version":"build-2803163510"},"reference-count":45,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,5,20]],"date-time":"2024-05-20T00:00:00Z","timestamp":1716163200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Fonden","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009907","name":"Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009907","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004836","name":"Danmarks Frie Forskningsfond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004836","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Anaesthesiol Scand"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Piperacillin\/tazobactam may be associated with less favourable outcomes than carbapenems in patients with severe bacterial infections, but the certainty of evidence is low.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The Empirical Meropenem versus Piperacillin\/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial is an investigator\u2010initiated, international, parallel\u2010group, randomised, open\u2010label, 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\u2009days. The primary outcome is 30\u2010day all\u2010cause mortality. The secondary outcomes are serious adverse reactions within 30\u2009days; isolation precautions due to resistant bacteria within 30\u2009days; days alive without life support and days alive and out of hospital within 30 and 90\u2009days; 90\u2010 and 180\u2010day all\u2010cause mortality and 180\u2010day health\u2010related quality of life. EMPRESS will use Bayesian statistical models with weak to somewhat sceptical neutral priors. Adaptive analyses will be conducted after follow\u2010up 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\u2009&lt;2.5%\u2010points) and response\u2010adaptive 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 \u226599% probability of conclusiveness across all scenarios.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aas.14441","type":"journal-article","created":{"date-parts":[[2024,5,21]],"date-time":"2024-05-21T01:54:00Z","timestamp":1716256440000},"page":"1107-1119","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Empirical meropenem versus piperacillin\/tazobactam for adult patients with sepsis (<scp>EMPRESS<\/scp>) trial: Protocol"],"prefix":"10.1111","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5799-7655","authenticated-orcid":false,"given":"Anders","family":"Granholm","sequence":"first","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital\u2014Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen 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