KBindER Clinical Trial

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.

In the setting of normal kidney function, serum potassium (K+) is maintained within a tight range (3.5–5.3 mEq/L) via renal excretion and cellular redistribution [1]. Hyperkalemia is considered severe if K+ is ≥ 6.0 mEq/L, with or without symptomatic muscle weakness/paralysis or electrocardiogram changes.

The findings from the new study of oral potassium binders in the treatment of acute hyperkalemia will inform decision-making guidelines for the treatment of acute hyperkalemia. The study has been published in the BMC Nephrology.

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)
• 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
• Treatment with other agents to lower potassium (insulin, albuterol, loop diuretics)

The findings from the study will inform decision-making guidelines on the role of oral potassium binders in the treatment of acute hyperkalemia.

Reference

Cañas, A.E., Troutt, H.R., Jiang, L. et al. A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia. BMC Nephrol 24, 89 (2023). https://doi.org/10.1186/s12882-023-03145-x