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NCT Number: NCT06120608

Evidence for Potassium Restriction in Hemodialysis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hyperkalemia, Diminished Renal Excretion Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIUSSS du Nord-de-l'Île-de-Montréal

Montreal, Quebec, H4J 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of prevalent dialysis patients recruited and retained for 3 months

    Time frame: 3 months

    Primary feasibility outcome

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

    Time frame: 3 months

Secondary outcomes

  1. Ratio of the number of randomized participants over the number of screened participants randomized

    Time frame: 3 months

    Secondary feasibility outcome

  2. Number of participants recruited 12 months into the trial

    Time frame: 3 months

    Secondary feasibility outcome

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

    Time frame: 3 months

    Secondary feasibility outcome

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

    Time frame: 3 months

    Secondary feasibility outcome

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

    Time frame: 3 months

  6. Peak serum potassium over the study period

    Time frame: 3 months

  7. Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events

    Time frame: 3 months

  8. Number of dialysis sessions with dialysate concentration < 2mmol/L

    Time frame: 3 months

  9. Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)

    Time frame: 3 months

  10. Total dose of potassium binders (g) over the study period

    Time frame: 3 months

  11. Number of participants taking potassium binders at 3 months

    Time frame: 3 months

  12. Healthy diet index 2020

    Time frame: 3 months

    Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100.

  13. Mediterranean diet score

    Time frame: 3 months

    0 to 100 score; higher score represents a better adherence to the Mediterranean diet

  14. Mediterranean-diet scale

    Time frame: 3 months

    Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)

  15. Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)

    Time frame: 3 months

  16. Number of servings/day of moderate to high total potassium food items

    Time frame: 3 months

  17. Ratio of plant to animal protein intake (g/g)

    Time frame: 3 months

  18. Subjective global assessment

    Time frame: 3 months

    Standardized subjective assessment of nutritional status performed by a dietitian. Final rating is either Well-nourished, Mildly/moderately malnourished or Severely malnourished with or without cachexia and/or sarcopenia.

  19. Albumin levels (g/L)

    Time frame: 3 months

  20. Normalized protein nitrogen appearance (g/kg/day)

    Time frame: 3 months

    calculated from urea reduction ratio

  21. Body mass index (kg/m2)

    Time frame: 3 months

  22. Change in weight (kg)

    Time frame: 3 months

  23. Satisfaction with food-related life

    Time frame: 3 months

    5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food

  24. Self-perceived impact on diet

    Time frame: 3 months

    "I changed my diet in the past 3 months based on the advice I received from the renal dietitian" (1-7 Likert scale with anchors)

  25. Self-perceived compliance with the dietary recommendations

    Time frame: 3 months

    "I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)

  26. Average monthly midweek pre-dialysis serum phosphate level (mmol/L)

    Time frame: 3 months

  27. Average monthly midweek pre-dialysis serum calcium level (mmol/L)

    Time frame: 3 months

  28. Pre-dialysis serum parathyroid hormone level (pmol/L)

    Time frame: 3 months

  29. Monthly average serum bicarbonate levels (mmol/L)

    Time frame: 3 months

  30. Inter-dialytic weight gain (kg/day)

    Time frame: 3 months

  31. 1-week average pre dialysis blood pressure (mmHg)

    Time frame: 3 months

Other outcomes

  1. Major cardiovascular events

    Time frame: 3 months

    Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  2. Standardised Outcomes in NephroloGy fatigue measure

    Time frame: 3 months

    3 questions answered on a 4-points Likert scale. The results of each question (rated 0 to 3) is summed up to obtain to total score (range 0 to 9)

  3. All-cause mortality

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: EvoKe-HD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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