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

Autor: W Frank Peacock, Adam J Singer, Brian E Driver, Matthew R Weir, Zubaid Rafique, Jeffrey Budden, Carol Moreno Quinn, Youyou Duanmu, Basmah Safdar, Jason J Bischof, Charles A Herzog, Stephen Boone, Karina M Soto-Ruiz
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMJ Open, Vol 13, Iss 6 (2023)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-071311
Popis: Introduction 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+) (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.Methods and analysis 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+ ≥5.8 mEq/L) will be enrolled. Participants will be randomised 1:1 to receive glucose (25 g intravenously
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