A Pilot Randomised Controlled Trial of a Targeted Dietary Approach to Potassium Management in Hemodialysis: A Clinical Research Protocol for the Evidence for Optimal Potassium Intake in Hemodialysis (EvoKe-HD) Study
Amélie Bernier-Jean, Rémi Goupil, François Madore, Jessica Dawson, Roxanne Papineau, Allison Jaure, Catherine ClaseBackground
Hyperkalemia affects more than one in five patients receiving maintenance hemodialysis and remains a major contributor to arrhythmias and sudden cardiac death. Traditional potassium restriction has centered on limiting fruits and vegetables, even as emerging evidence challenges the assumption that all high-potassium foods pose equal risk. Meanwhile, awareness of potassium additives has grown, and recommendations to avoid additive-containing processed foods have been layered onto existing restrictions. Together, the uncertainties around long-standing to newer recommendations create guidance that is difficult for many patients to navigate.
Objective
To describe the protocol for EvoKe-HD, a pilot randomised controlled trial evaluating the feasibility, acceptability and safety of a targeted dietary counselling strategy for potassium management in hemodialysis.
Design
Two-arm, 1:1 randomised, parallel-group feasibility trial.
Setting
Two dialysis units at the CIUSSS du Nord-de-l’Île-de-Montréal, Canada.
Patients
Adults receiving thrice-weekly maintenance hemodialysis with elevated pre-dialysis serum potassium levels or receiving regular potassium binder therapy.
Measurements
The primary feasibility outcome is the proportion of eligible patients who enrol and complete the 3-month assessment. The main exploratory clinical outcome is mean mid-week pre-dialysis serum potassium during follow-up. Secondary and exploratory outcomes include hyperkalemia events, potassium binder use, dialysate potassium adjustments, biochemical measures, dietary outcomes, patient-reported outcomes, and process evaluation measures.
Methods
Participants are randomised to monthly targeted dietary counselling focused on reducing potassium additives and selected high-impact foods, or to monthly standard potassium-restriction counselling based primarily on total potassium content. Feasibility outcomes will be summarized with 95% confidence intervals. Mean follow-up serum potassium will be analysed using linear mixed-effects model adjusted for baseline potassium and sex, with a random intercept for participant.
Results
Recruitment began in June 2025 and was completed in January 2026. The last study visit was completed in March 2026. Process evaluation interviews are expected to be completed in July 2026.
Limitations
As a single-centre pilot feasibility trial, EvoKe-HD is not powered to evaluate definitive effects on serum potassium, hyperkalemia events, or other clinical outcomes.
Conclusions
EvoKe-HD will assess whether a targeted potassium counselling strategy can be implemented in routine hemodialysis care and will provide feasibility and process evaluation data to inform the design of a larger trial.