Evidence for Potassium Restriction in Hemodialysis

NCT06120608 | Active Not Recruiting

• 1 other identifier: 2024-2643
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia, Diminished Renal Excretion

Keywords

Potassium; Hyperkalemia; Hemodialysis; Nutrition

Outcome Measures

Primary Outcomes (2)

• Percentage of prevalent dialysis patients recruited and retained for 3 months

  Primary feasibility outcome

  3 months

• Change in average mid-week predialysis potassium level during the study period

  3 months

Secondary Outcomes (31)

• Ratio of the number of randomized participants over the number of screened participants randomized

  3 months

• Number of participants recruited 12 months into the trial

  3 months

• Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors

  3 months

• Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors

  3 months

• Average monthly midweek pre-dialysis serum potassium level (mmol/L)

  3 months

Other Outcomes (3)

• Major cardiovascular events

  3 months

• Standardised Outcomes in NephroloGy fatigue measure

  3 months

• All-cause mortality

  3 months

Study Arms (2)

Restriction high bioavailability potassium sources

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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.

Behavioral: Traditional approach

Interventions

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

Restriction high bioavailability potassium sources

Traditional approach 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

CIUSSS du Nord-de-l'Île-de-Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 7, 2023
• Study Start: June 17, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)