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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
- Source :
- BMJ Open, Vol 13, Iss 6 (2023)
- Publication Year :
- 2023
- Publisher :
- BMJ Publishing Group, 2023.
-
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+) (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
- Subjects :
- Medicine
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 13
- Issue :
- 6
- Database :
- Directory of Open Access Journals
- Journal :
- BMJ Open
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.fa530fa7e0e34d11b876dba135ca4259
- Document Type :
- article
- Full Text :
- https://doi.org/10.1136/bmjopen-2022-071311