Sökning: onr:"swepub:oai:lup.lub.lu.se:6c1f380b-16e8-45c8-b548-141c8b1f1c73" > Empirical meropenem...
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000 | 05114naa a2200553 4500 | |
001 | oai:lup.lub.lu.se:6c1f380b-16e8-45c8-b548-141c8b1f1c73 | |
003 | SwePub | |
008 | 240614| | |||||||||||000 ||eng| | |
024 | 7 | a https://lup.lub.lu.se/record/6c1f380b-16e8-45c8-b548-141c8b1f1c732 URI |
024 | 7 | a https://doi.org/10.1111/aas.144412 DOI |
040 | a (SwePub)lu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a art2 swepub-publicationtype |
072 | 7 | a ref2 swepub-contenttype |
100 | 1 | a Granholm, Andersu Copenhagen University Hospital4 aut |
245 | 1 0 | a Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial : Protocol |
520 | a 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. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng |
653 | a adaptive clinical trial | |
653 | a carbapenems | |
653 | a empirical antibiotics | |
653 | a meropenem | |
653 | a piperacillin/tazobactam | |
653 | a randomised clinical trial | |
653 | a sepsis | |
653 | a septic shock | |
700 | 1 | a Munch, Marie Warreru Copenhagen University Hospital4 aut |
700 | 1 | a Meier, Nicku CRIC - Collaboration for Research in Intensive Care,Copenhagen University Hospital4 aut |
700 | 1 | a Sjövall, Fredriku Lund 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 Hospital4 aut0 (Swepub:lu)expb-fsa |
700 | 1 | a Helleberg, Marieu Copenhagen University Hospital,University of Copenhagen4 aut |
700 | 1 | a Hertz, Frederik Boëtiusu University of Copenhagen,Copenhagen University Hospital4 aut |
700 | 1 | a Kaas-Hansen, Benjamin Skovu University of Copenhagen,Copenhagen University Hospital4 aut |
700 | 1 | a Thorsen-Meyer, Hans Christianu Copenhagen University Hospital4 aut |
700 | 1 | a Andersen, Lars Wiuffu Aarhus University,Aarhus University Hospital4 aut |
700 | 1 | a Rasmussen, Bodil Steenu Aalborg University Hospital,Aalborg University4 aut |
700 | 1 | a Andersen, Jakob Steenu Copenhagen University Hospital4 aut |
700 | 1 | a Albertsen, Trine Lynge4 aut |
700 | 1 | a Kjær, Maj Brit Nørregaardu Copenhagen University Hospital4 aut |
700 | 1 | a Jensen, Aksel Karl Georgu University of Copenhagen4 aut |
700 | 1 | a Lange, Theisu University of Copenhagen4 aut |
700 | 1 | a Perner, Andersu University of Copenhagen,Copenhagen University Hospital4 aut |
700 | 1 | a Møller, Morten Hylanderu University of Copenhagen,Copenhagen University Hospital4 aut |
710 | 2 | a Copenhagen University Hospitalb CRIC - Collaboration for Research in Intensive Care4 org |
773 | 0 | t Acta Anaesthesiologica Scandinavicax 0001-5172 |
856 | 4 | u http://dx.doi.org/10.1111/aas.14441x freey FULLTEXT |
856 | 4 8 | u https://lup.lub.lu.se/record/6c1f380b-16e8-45c8-b548-141c8b1f1c73 |
856 | 4 8 | u https://doi.org/10.1111/aas.14441 |
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