NCT06120608

Evidence for Potassium Restriction in Hemodialysis

Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD) Pilot Parallel Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

Detailed description

Sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/L on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last three months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study. The study will be successful if 30% or more of the eligible patients agree to participate and complete the 3-month assessment.

Conditions

• Hyperkalemia, Diminished Renal Excretion

Interventions

Type	Name	Description
BEHAVIORAL	Novel dietary approach focused on restricting the intake of highly bioavailable potassium	Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee.
BEHAVIORAL	Traditional approach	Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants.

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-03-12
• Completion: 2026-03-12
• First posted: 2023-11-07
• Last updated: 2025-12-16

Locations

1 site across 1 country: Canada