{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T05:10:47Z","timestamp":1773033047056,"version":"3.50.1"},"reference-count":40,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Foundation","doi-asserted-by":"publisher","award":["NNF23OC0085106"],"award-info":[{"award-number":["NNF23OC0085106"]}],"id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004836","name":"Danmarks Frie Forskningsfond","doi-asserted-by":"publisher","award":["4308\u201000210B"],"award-info":[{"award-number":["4308\u201000210B"]}],"id":[{"id":"10.13039\/501100004836","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\/100007403","name":"Dagmar Marshalls Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007403","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":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Intravenous albumin is used for resuscitation of adult intensive care unit (ICU) patients with shock and substitution in those with hypoalbuminemia, which is common in critically ill patients. There is, however, substantial clinical practice variation as it is uncertain if albumin use improves patient\u2010important outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:italic>INCEPT\u2010Albumin<\/jats:italic>\n                      domain is an investigator\u2010initiated, open\u2010label domain with an integrated feasibility phase on the international, pragmatic, parallel\u2010group, randomised, embedded, multifactorial, adaptive\n                      <jats:italic>Intensive Care Platform Trial (INCEPT)<\/jats:italic>\n                      . Adult acutely admitted ICU patients with shock irrespective of its cause will be randomised to albumin versus no albumin use for resuscitation and substitution while in the ICU for a maximum of 90\u2009days. The primary outcome is days alive without life support at 30\u2009days. Secondary outcomes include 30\u2010, 90\u2010, and 180\u2010day all\u2010cause mortality; days alive without life support at 90\u2009days; days alive out of hospital at 30 and 90\u2009days; days free of delirium at 30\u2009days; health\u2010related quality of life and cognitive function at 180\u2009days; and serious adverse reactions at 30 and 90\u2009days. Analyses will primarily be conducted in the intention\u2010to\u2010treat population using Bayesian statistical models with neutral, weakly informative priors. We will assess feasibility after 200 participants and conduct adaptive analyses after follow\u2010up for the primary outcome of 1000 participants and every additional 250 participants to a maximum of 10,000, with adaptive stopping for superiority\/inferiority and practical equivalence (mean difference in the primary outcome &lt;\u20091\u2009day). Allocation will initially be equal, followed by response\u2010adaptive randomisation with minimum 40% allocation to each arm. Expected sample sizes across different scenarios range from 1137 to 3547 participants, with approximately 100% probabilities of conclusiveness across scenarios.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      <jats:italic>INCEPT\u2010Albumin<\/jats:italic>\n                      will with high probability provide conclusive results and inform clinical practice regarding albumin versus no albumin use in adult acutely admitted ICU patients with shock.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/aas.70203","type":"journal-article","created":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:24:23Z","timestamp":1771287863000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Albumin for Adult\n                    <scp>ICU<\/scp>\n                    Patients With Shock: Protocol for the\n                    <scp>INCEPT<\/scp>\n                    \u2010Albumin Platform Trial Domain"],"prefix":"10.1111","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1840-1596","authenticated-orcid":false,"given":"Tine Sylvest","family":"Meyhoff","sequence":"first","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"Perner","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0442-0032","authenticated-orcid":false,"given":"Praleene","family":"Sivapalan","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen Louise","family":"Ellekj\u00e6r","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aksel Karl Georg","family":"Jensen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Section of Biostatistics, Department of Public Health University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rikke Faebo","family":"Larsen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maj\u2010Brit N\u00f8rregaard","family":"Kj\u00e6r","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin Skov","family":"Kaas\u2010Hansen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6807-8347","authenticated-orcid":false,"given":"Theis","family":"Lange","sequence":"additional","affiliation":[{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Section of Biostatistics, Department of Public Health University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lasse","family":"Gr\u00f8nnings\u00e6ter","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Division of Emergencies and Critical Care Oslo University Hospital  Oslo Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0444-8553","authenticated-orcid":false,"given":"Maria","family":"Cronhjort","sequence":"additional","affiliation":[{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Department of Clinical Science and Education, S\u00f6dersjukhuset Karolinska Institutet  Stockholm Sweden"},{"name":"Department of Clinical Sciences, Danderyd Hospital Karolinska Institutet  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen Andrea","family":"Pfortmueller","sequence":"additional","affiliation":[{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Department of Intensive Care Medicine, Inselspital University Hospital Bern  Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederik","family":"Keus","sequence":"additional","affiliation":[{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Department of Critical Care, University Medical Center Groningen University of Groningen  Groningen the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin Ingi","family":"Sigurdsson","sequence":"additional","affiliation":[{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Faculty of Medicine University of Iceland  Reykjavik Iceland"},{"name":"Division of Anaesthesiology and Critical Care Medicine Landspitali \u2013 The National University Hospital of Reykjavik  Reykjavik Iceland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4250-7523","authenticated-orcid":false,"given":"Erika","family":"Wilkman","sequence":"additional","affiliation":[{"name":"Perioperative and Intensive Care Helsinki University Hospital and University of Helsinki  Helsinki Finland"}],"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 \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5799-7655","authenticated-orcid":false,"given":"Anders","family":"Granholm","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital \u2013 Rigshospitalet  Copenhagen Denmark"},{"name":"Collaboration for Research in Intensive Care (CRIC)  Copenhagen Denmark"},{"name":"Section of Biostatistics, Department of Public Health University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,16]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1208943"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.CCM.0000201896.45809.E3"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2202707"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134\u2010023\u201007114\u20108"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1208627"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.14479"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000658\u2010200303000\u201000005"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD000567.pub7"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcrc.2018.11.031"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1305727"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040232"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134\u2010021\u201006506\u2010y"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2024.02.049"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134\u2010024\u201007369\u20109"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.14359"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41573\u2010019\u20100034\u20103"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.70023"},{"key":"e_1_2_9_19_1","unstructured":"INCEPT \u201cThe Intensive Care Platform Trial \u201d2025 accessed December 1 2025 https:\/\/www.incept.dk."},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj\u20102024\u2010081477"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m115"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010023\u201001963\u2010z"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136\u2010011\u20109903\u2010x"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.057817"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.11.002"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(24)01295\u20109"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.70042"},{"key":"e_1_2_9_28_1","unstructured":"United States Food and Drug Administration \u201cAdaptive Designs for Clinical Trials of Drugs and Biologics \u2010 Guidance for Industry \u201dGuidance Document 2019 accessed February 27 2025 https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/adaptive\u2010design\u2010clinical\u2010trials\u2010drugs\u2010and\u2010biologics\u2010guidance\u2010industry."},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.13048"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.050051"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.5770\/cgj.23.463"},{"key":"e_1_2_9_32_1","unstructured":"United States Food and Drug Administration \u201cAdjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products \u201dGuidance Document 2023 https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/adjusting\u2010covariates\u2010randomized\u2010clinical\u2010trials\u2010drugs\u2010and\u2010biological\u2010products."},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201411\u20102125CP"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1201\/9780429492259"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.21105\/joss.04284"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/aas.14441"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000006556"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11096\u2010016\u20100257\u2010x"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000005637"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201401\u20100056CP"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1214\/22\u2010STS865"}],"container-title":["Acta Anaesthesiologica Scandinavica"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aas.70203","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/aas.70203","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/aas.70203","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T04:21:17Z","timestamp":1773030077000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/aas.70203"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,16]]},"references-count":40,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1111\/aas.70203"],"URL":"https:\/\/doi.org\/10.1111\/aas.70203","archive":["Portico"],"relation":{},"ISSN":["0001-5172","1399-6576"],"issn-type":[{"value":"0001-5172","type":"print"},{"value":"1399-6576","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,16]]},"assertion":[{"value":"2026-01-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70203"}}