Standardizing emergency department hyperkalemia management: The PLATINUM study
Rafique Z, Safdar B, Duanmu Y, Boone S, Bischof JJ, Beiser DG, D'Etienne J, Driver BE, Fermann GJ, Klausner HA, Lagina A, Robinson D, Singer AJ, Stopyra JP, and Peacock F. Standardizing emergency department hyperkalemia management: The PLATINUM study. Academic Emergency Medicine 2021; 28(SUPPL 1):S203-S204.
Academic Emergency Medicine
Background and Objectives: Although hyperkalemia (HK) is common and potentially life-threatening, there is limited data defining an ED standard of care (SoC). ED treatment is mostly based on small studies, anecdotal experience, and historical standards. The lack of a SoC has resulted in wide practice variability and created challenges for the control arm of any investigation. The PLATINUM (Patiromer utiLity as an Adjunct Treatment In patients Needing Urgent hyperkalemia Management) study has proposed an ED SoC HK treatment regimen.
Methods: This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. After informed consent, ED subjects ≥18 years old with potassium (K) ≥ 5.8 mEq/L are enrolled. Exclusions are clinically significant arrhythmia, hemodynamic instability, overdose on K, known bowel obstruction, K binder use within 7 days, expected dialysis within 6 hours of enrollment, hypersensitivity to patiromer, participation in another studyprior, inability to take study drug, life expectancy of <6 >months, or pregnant/breastfeeding. No more than 50% will be current hemodialysis recipients. Upon enrollment, subjects are randomized to treatment or control in a 1:1 ratio, and all receive SoC therapy defined as regular insulin 5U IV plus dextrose 25 g IV plus albuterol 10 mg nebulized. Controls receive blinded placebo and the treatment group receives blinded patiromer 25.2 g by mouth. Serum K is drawn at baseline and every 2 hours up to 10 hours or until ED discharge. Efficacy will be evaluated by comparing Net Clinical Benefit (NCB) at 6 hours between study arms as defined by the mean change in number of interventions less mean change in serum K. Safety analysis will include frequency and severity of adverse events, ECG changes, hypokalemia and hypomagnesemia.
Results: A total of 300 subjects will be enrolled from 30 sites across the United States. A modified intention to treat analysis will be used for the primary endpoint. Proportions will be analyzed using Cochran-Mantel- Haenszel methods while continuous variables will be analyzed using analysis of covariance.
Conclusion: The Platinum study is the first randomized controlled trial to evaluate the efficacy and safety of a standard combination of insulin, dextrose, and albuterol with or without an oral K binder for treatment of HK. In addition, the 150-patient control arm may help define the optimal ED HK SoC management.