An interventional study of Novel dietary approach focused on restricting the intake of highly bioavailable potassium and Traditional approach in Hyperkalemia, Diminished Renal Excretion, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Treatment
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.
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.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 50 is below the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Percentage of prevalent dialysis patients recruited and retained for 3 months
Primary feasibility outcome
Time frame: 3 months
Change in average mid-week predialysis potassium level during the study period
Time frame: 3 months
Ratio of the number of randomized participants over the number of screened participants randomized
Secondary feasibility outcome
Time frame: 3 months
Number of participants recruited 12 months into the trial
Secondary feasibility outcome
Time frame: 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
Secondary feasibility outcome
Time frame: 3 months
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
Secondary feasibility outcome
Time frame: 3 months
Average monthly midweek pre-dialysis serum potassium level (mmol/L)
Time frame: 3 months
Peak serum potassium over the study period
Time frame: 3 months
Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events
Time frame: 3 months
Number of dialysis sessions with dialysate concentration < 2mmol/L
Time frame: 3 months
Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)
Time frame: 3 months
Total dose of potassium binders (g) over the study period
Time frame: 3 months
Number of participants taking potassium binders at 3 months
Time frame: 3 months
Healthy diet index 2020
Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100.
Time frame: 3 months
Mediterranean diet score
0 to 100 score; higher score represents a better adherence to the Mediterranean diet
Time frame: 3 months
Mediterranean-diet scale
Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)
Time frame: 3 months
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)
Time frame: 3 months
Number of servings/day of moderate to high total potassium food items
Time frame: 3 months
Ratio of plant to animal protein intake (g/g)
Time frame: 3 months
Subjective global assessment
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.
Time frame: 3 months
Albumin levels (g/L)
Time frame: 3 months
Normalized protein nitrogen appearance (g/kg/day)
calculated from urea reduction ratio
Time frame: 3 months
Body mass index (kg/m2)
Time frame: 3 months
Change in weight (kg)
Time frame: 3 months
Satisfaction with food-related life
5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food
Time frame: 3 months
Self-perceived impact on diet
"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)
Time frame: 3 months
Self-perceived compliance with the dietary recommendations
"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)
Time frame: 3 months
Average monthly midweek pre-dialysis serum phosphate level (mmol/L)
Time frame: 3 months
Average monthly midweek pre-dialysis serum calcium level (mmol/L)
Time frame: 3 months
Pre-dialysis serum parathyroid hormone level (pmol/L)
Time frame: 3 months
Monthly average serum bicarbonate levels (mmol/L)
Time frame: 3 months
Inter-dialytic weight gain (kg/day)
Time frame: 3 months
1-week average pre dialysis blood pressure (mmHg)
Time frame: 3 months
Major cardiovascular events
Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time frame: 3 months
Standardised Outcomes in NephroloGy fatigue measure
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)
Time frame: 3 months
All-cause mortality
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal