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RCT·nephrology, emergency medicine, internal medicine, clinical trial, cardiology·PMC10074796

A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia

BMC Nephrology · 10 authors, 4 centres

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The KBindER trial is the first head-to-head randomized controlled trial protocol comparing three oral potassium binders (SPS, patiromer, and sodium zirconium cyclosilicate) plus a nonspecific laxative control (polyethylene glycol 3350) for acute hyperkalemia. The planned cohort is 80 patients (20 per group), with primary endpoints of potassium change at 2 and 4 hours and secondary endpoints including length of hospital stay, next-morning potassium, GI side effects, and palatability.

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RCT

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nephrology

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ORIGINAL PAPER

PMC10074796

A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia

BMC Nephrology

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ABSTRACT

Background The KBindER (K + Binders in Emergency Room and hospitalized patients) clinical trial is the first head-to-head evaluation of oral potassium binders (cation-exchange resins) for acute hyperkalemia therapy. Methods Emergency room and hospitalized patients with a blood potassium level ≥ 5.5 mEq/L are randomized to one of four study groups: potassium binder drug (sodium polystyrene sulfonate, patiromer, or sodium zirconium cyclosilicate) or nonspecific laxative (polyethylene glycol). Exclusion criteria include recent bowel surgery, ileus, diabetic ketoacidosis, or anticipated dialysis treatment within 4 h of treatment drug. Primary endpoints include change in potassium level at 2 and 4 h after treatment drug. Length of hospital stay, next-morning potassium level, gastrointestinal side effects and palatability will also be analyzed. We are aiming for a final cohort of 80 patients with complete data endpoints (20 per group) for comparative statistics including multivariate adjustment for kidney function, diabetes mellitus, congestive heart failure, metabolic acidosis, renin-angiotensin-aldosterone system inhibitor prescription, and treatment with other agents to lower potassium (insulin, albuterol, loop diuretics). Discussion The findings from our study will inform decision-making guidelines on the role of oral potassium binders in the treatment of acute hyperkalemia. Trial registration ClinicalTrials.gov Identifier: NCT04585542 . Registered 14 October 2020. Supplementary Information The online version contains supplementary material available at 10.1186/s12882-023-03145-x.

CITATION EXPORT

Alejandro E. Cañas, Hayden R. Troutt, Luohua Jiang et al.. A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia. BMC Nephrology. (2023). https://doi.org/10.1186/s12882-023-03145-x

AUTHORS

10 · 4 CENTRES

Alejandro E. Cañas, Hayden R. Troutt, Luohua Jiang, Sam Tonthat, Omar Darwish, Antoney Ferrey, Shahram Lotfipour, Kamyar Kalantar-Zadeh, Ramy Hanna, Wei Ling Lau

1grid.417319.90000 0004 0434 883XDivision of Nephrology, Department of Medicine, University of California-Irvine, 101 The City Drive South, City Tower, Suite 400, Orange, CA 92868 USA
2grid.266093.80000 0001 0668 7243Department of Epidemiology & Biostatistics, Program in Public Health, University of California-Irvine, Irvine, USA
3grid.417319.90000 0004 0434 883XDepartment of Medicine, University of California-Irvine, Orange, USA
4grid.417319.90000 0004 0434 883XDepartment of Emergency Medicine, University of California-Irvine, Orange, USA