{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T01:28:30Z","timestamp":1789003710063,"version":"build-2803163510"},"reference-count":45,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2021,8,26]],"date-time":"2021-08-26T00:00:00Z","timestamp":1629936000000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009594","name":"P\u00e9csi\n Tudom\u00e1nyegyetem","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009594","id-type":"DOI","asserted-by":"publisher"}]},{"name":"European\n Commission, Economic Development and Innovation Operational\n Programme","award":["GINOP-2.3.2-15-2016-00048 - STAY\n ALIVE"],"award-info":[{"award-number":["GINOP-2.3.2-15-2016-00048 - STAY\n ALIVE"]}]},{"name":"European\n Commission, Economic Development and Innovation Operational\n Programme","award":["GINOP-2.3.4-15-2020-00010"],"award-info":[{"award-number":["GINOP-2.3.4-15-2020-00010"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2021,8]]},"abstract":"\n Introduction<\/jats:title>\n Sepsis and septic shock have mortality rates between 20% and 50%. In\n sepsis, the immune response becomes dysregulated, which leads to an\n imbalance between proinflammatory and anti-inflammatory mediators. When\n standard therapeutic measures fail to improve patients\u2019 condition,\n additional therapeutic alternatives are applied to reduce morbidity and\n mortality. One of the most recent alternatives is extracorporeal\n cytokine adsorption with a device called CytoSorb. This study aims to\n compare the efficacy of standard medical therapy and continuous\n extracorporeal cytokine removal with CytoSorb therapy in patients with\n early refractory septic shock. Furthermore, we compare the dosing of\n CytoSorb adsorber device changed every 12 or 24 hours.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n It is a prospective, randomised, controlled, open-label,\n international, multicentre, phase III study. Patients fulfilling the\n inclusion criteria will be randomly assigned to receive standard medical\n therapy (group A) or\u2014in addition to standard treatment\u2014CytoSorb therapy.\n CytoSorb treatment will be continuous and last for at least 24 hours,\n CytoSorb adsorber device will be changed every 12 (group B) or 24 hours\n (group C). Our primary outcome is shock reversal (no further need or a\n reduced (\u226410% of the maximum dose) vasopressor requirement for 3 hours)\n and time to shock reversal (number of hours elapsed from the start of\n the treatment to shock reversal).<\/jats:p>\n Based on sample size calculation, 135 patients (1:1:1) will need to\n be enrolled in the study. A predefined interim analysis will be\n performed after reaching 50% of the planned sample size, therefore, the\n corrected level of significance (p value) will be 0.0294.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n Ethics approval was obtained from the Scientific and Research Ethics\n Committee of the Hungarian Medical Research Council (OGY\u00c9I\/65049\/2020).\n Results will be submitted for publication in a peer-reviewed\n journal.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT04742764<\/jats:ext-link>\n ; Pre-results.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050464","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T11:51:29Z","timestamp":1667562689000},"page":"e050464","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS):\n protocol of a 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