{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:25:44Z","timestamp":1787509544391,"version":"build-2736575974"},"reference-count":45,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2023,6,12]],"date-time":"2023-06-12T00:00:00Z","timestamp":1686528000000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"CSL Vifor","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,5,11]]},"published-print":{"date-parts":[[2023,6]]},"abstract":"\n Introduction<\/jats:title>\n \n Hyperkalaemia is common, life-threatening and often requires emergency department (ED) management; however, no standardised ED treatment protocol exists. Common treatments transiently reducing serum potassium (K\n +<\/jats:sup>\n ) (including albuterol, glucose and insulin) may cause hypoglycaemia. We outline the design and rationale of the Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalaemia Management (PLATINUM) study, which will be the largest ED randomised controlled hyperkalaemia trial ever performed, enabling assessment of a standardised approach to hyperkalaemia management, as well as establishing a new evaluation parameter (net clinical benefit) for acute hyperkalaemia treatment investigations.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n \n PLATINUM is a Phase 4, multicentre, randomised, double-blind, placebo-controlled study in participants who present to the ED at approximately 30 US sites. Approximately 300 adult participants with hyperkalaemia (K\n +<\/jats:sup>\n \u22655.8\u2009mEq\/L) will be enrolled. Participants will be randomised 1:1 to receive glucose (25\u2009g intravenously <15\u2009min before insulin), insulin (5 units intravenous bolus) and aerosolised albuterol (10\u2009mg over 30\u2009min), followed by a single oral dose of either 25.2\u2009g patiromer or placebo, with a second dose of patiromer (8.4\u2009g) or placebo after 24 hours. The primary endpoint is net clinical benefit, defined as the mean change in the number of additional interventions less the mean change in serum K\n +<\/jats:sup>\n , at hour 6. Secondary endpoints are net clinical benefit at hour 4, proportion of participants without additional K\n +<\/jats:sup>\n -related medical interventions, number of additional K\n +<\/jats:sup>\n -related interventions and proportion of participants with sustained K\n +<\/jats:sup>\n reduction (K\n +<\/jats:sup>\n \u22645.5\u2009mEq\/L). Safety endpoints are the incidence of adverse events, and severity of changes in serum K\n +<\/jats:sup>\n and magnesium.\n <\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n A central Institutional Review Board (IRB) and Ethics Committee provided protocol approval (#20201569), with subsequent approval by local IRBs at each site, and participants will provide written consent. Primary results will be published in peer-reviewed manuscripts promptly following study completion.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT04443608<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-071311","type":"journal-article","created":{"date-parts":[[2023,6,12]],"date-time":"2023-06-12T11:01:12Z","timestamp":1686567672000},"page":"e071311","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): design of a multicentre, randomised, double-blind, placebo-controlled, parallel-group study"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04443608","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Zubaid","family":"Rafique","sequence":"first","affiliation":[{"name":"Henry JN Taub Department of 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R","family":"Weir","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam J","family":"Singer","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, SUNY Stony Brook, Stony Brook, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Boone","sequence":"additional","affiliation":[{"name":"Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karina M","family":"Soto-Ruiz","sequence":"additional","affiliation":[{"name":"Comprehensive Research Associates, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Frank","family":"Peacock","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Baylor College 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