Evidence for Potassium Restriction in Hemodialysis

NCT ID: NCT06120608

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-03-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Restriction high bioavailability potassium sources

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.

Group Type: EXPERIMENTAL

Novel dietary approach focused on restricting the intake of highly bioavailable potassium

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Traditional approach

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥18 years or older
• Receiving hemodialysis 3 times/week for ≥ 3 months
• Has at least two pre-dialysis serum potassium levels ≥5.2 mmol/L on any analysis in the past 3 months OR the most recent pre-dialysis serum potassium value ≥ 4.6 mmol/L and is currently prescribed a potassium-binding agent at a regular frequency (defined as ≥ once per week).
• Can speak and understand French or English
• Has not missed more than 1 dialysis session in the previous 3 months.
• Is capable of providing informed consent.

Exclusion Criteria

• Is not expected to survive beyond 6 months
• Does not control their dietary intake (e.g., residents of high-dependency nursing homes)
• Significant cognitive impairment precluding understanding of the dietary recommendations.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Amélie Bernier-Jean

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CIUSSS du Nord-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2024-2643

Identifier Type: -

Identifier Source: org_study_id