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

Authors

Zubaid Rafique
Jeffrey Budden
Carol Moreno Quinn
Youyou Duanmu
Basmah Safdar
Jason J Bischof
Brian E Driver
Charles A Herzog
Matthew R Weir
Adam J Singer
Stephen Boone
Karina M Soto-Ruiz
W Frank Peacock

Publication Date

6-12-2023

Journal

BMJ Open

DOI

10.1136/bmjopen-2022-071311

PMID

37308268

PMCID

PMC10277034

PubMedCentral® Posted Date

6-12-2023

PubMedCentral® Full Text Version

Post-Print

Published Open-Access

yes

Keywords

Adult, Humans, Albuterol, Ethics Committees, Research, Glucose, Hyperkalemia, Insulin, Clinical Trials, Phase IV as Topic, Randomized Controlled Trials as Topic, Multicenter Studies as Topic

Abstract

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

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

ETHICS AND DISSEMINATION: 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.

TRIAL REGISTRATION NUMBER: NCT04443608.

Comments

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