{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:32:00Z","timestamp":1747182720389,"version":"3.40.5"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,12,26]],"date-time":"2019-12-26T00:00:00Z","timestamp":1577318400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Fonden","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009708","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":[[2020,3]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>In patients with septic shock, mortality is high, and survivors experience long\u2010term physical, mental and social impairments. The ongoing Conservative vs Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial assesses the benefits and harms of a restrictive vs standard\u2010care intravenous (IV) fluid therapy. The hypothesis is that IV fluid restriction improves patient\u2010important long\u2010term outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the predefined patient\u2010important long\u2010term outcomes in patients randomised into the CLASSIC trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this pre\u2010planned follow\u2010up study of the CLASSIC trial, we will assess all\u2010cause mortality, health\u2010related quality of life (HRQoL) and cognitive function 1\u00a0year after randomisation in the two intervention groups. The 1\u2010year mortality will be collected from electronic patient records or central national registries in most participating countries. We will contact survivors and assess EuroQol 5\u2010Dimension, \u20105\u2010Level (EQ\u20105D\u20105L) and EuroQol\u2010Visual Analogue Scale and Montreal Cognitive Assessment 5\u2010minute protocol score. We will analyse mortality by logistic regression and use general linear models to assess HRQoL and cognitive function.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>With this pre\u2010planned follow\u2010up study of the CLASSIC trial, we will provide patient\u2010important data on long\u2010term survival, HRQoL and cognitive function of restrictive vs standard\u2010care IV fluid therapy in patients with septic shock.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aas.13519","type":"journal-article","created":{"date-parts":[[2019,12,12]],"date-time":"2019-12-12T08:25:06Z","timestamp":1576139106000},"page":"410-416","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Long\u2010term patient\u2010important outcomes after septic shock: A protocol for 1\u2010year follow\u2010up of the CLASSIC trial"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6536-0504","authenticated-orcid":false,"given":"Maj\u2010Brit N.","family":"Kj\u00e6r","sequence":"first","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"},{"name":"Centre for Research in Intensive Care (CRIC) Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1840-1596","authenticated-orcid":false,"given":"Tine S.","family":"Meyhoff","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"},{"name":"Centre for Research in Intensive Care (CRIC) Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5832-2262","authenticated-orcid":false,"given":"Martin B.","family":"Madsen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter B.","family":"Hjortrup","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6378-9673","authenticated-orcid":false,"given":"Morten Hylander","family":"M\u00f8ller","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"},{"name":"Centre for Research in Intensive Care (CRIC) Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingrid","family":"Egerod","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"},{"name":"Centre for Research in Intensive Care (CRIC) Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00f8rn","family":"Wetterslev","sequence":"additional","affiliation":[{"name":"Centre for Research in Intensive Care (CRIC) Copenhagen Denmark"},{"name":"Copenhagen Trial Unit Centre for Clinical Intervention Research Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theis","family":"Lange","sequence":"additional","affiliation":[{"name":"Section of Biostatistics Department of Public Health University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Cronhjort","sequence":"additional","affiliation":[{"name":"Section of Anaesthesia and Intensive Care Department of Clinical Science and Education S\u00f6dersjukhuset Karolinska Institutet Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6157-5359","authenticated-orcid":false,"given":"Jon H.","family":"Laake","sequence":"additional","affiliation":[{"name":"Division of Emergencies and Critical Care Department of Anaesthesiology Oslo University Hospital, Rikshospitalet Oslo Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan M.","family":"Jakob","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Medicine University Hospital Bern (Inselspital) University of Bern Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marek","family":"Nalos","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit 1. Interni klinika Fakultni Nemocnice Plzen Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3921-4423","authenticated-orcid":false,"given":"Ville","family":"Pettil\u00e4","sequence":"additional","affiliation":[{"name":"Division of Intensive Care Medicine Department of Anaesthesiology, Intensive Care and Pain Medicine Helsinki University Hospital University of Helsinki Helsinki Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iwan C. C.","family":"van der Horst","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Maastricht University Medical Center+ University Maastricht Maastrict The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlies","family":"Ostermann","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Guy's and St Thomas' Hospital London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Mouncey","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit Intensive Care National Audit &amp; Research Centre (ICNARC) London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurizio","family":"Cecconi","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Medicine Humanitas Research Hospital Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ricard","family":"Ferrer","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Hospital Vall d'Hebron Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manu L. 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