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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of the number of randomized participants over the number of screened participants randomized | Secondary feasibility outcome | 3 months |
| Number of participants recruited 12 months into the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular events | Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIUSSS du Nord-de-l'Île-de-Montréal | Montreal | Quebec | H4J 1C5 | Canada |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
Secondary feasibility outcome
| 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 | 3 months |
| Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors | Secondary feasibility outcome | 3 months |
| Average monthly midweek pre-dialysis serum potassium level (mmol/L) | 3 months |
| Peak serum potassium over the study period | 3 months |
| Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events | 3 months |
| Number of dialysis sessions with dialysate concentration < 2mmol/L | 3 months |
| Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L) | 3 months |
| Total dose of potassium binders (g) over the study period | 3 months |
| Number of participants taking potassium binders at 3 months | 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. | 3 months |
| Mediterranean diet score | 0 to 100 score; higher score represents a better adherence to the Mediterranean diet | 3 months |
| Mediterranean-diet scale | Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence) | 3 months |
| Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes) | 3 months |
| Number of servings/day of moderate to high total potassium food items | 3 months |
| Ratio of plant to animal protein intake (g/g) | 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. | 3 months |
| Albumin levels (g/L) | 3 months |
| Normalized protein nitrogen appearance (g/kg/day) | calculated from urea reduction ratio | 3 months |
| Body mass index (kg/m2) | 3 months |
| Change in weight (kg) | 3 months |
| Satisfaction with food-related life | 5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food | 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) | 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) | 3 months |
| Average monthly midweek pre-dialysis serum phosphate level (mmol/L) | 3 months |
| Average monthly midweek pre-dialysis serum calcium level (mmol/L) | 3 months |
| Pre-dialysis serum parathyroid hormone level (pmol/L) | 3 months |
| Monthly average serum bicarbonate levels (mmol/L) | 3 months |
| Inter-dialytic weight gain (kg/day) | 3 months |
| 1-week average pre dialysis blood pressure (mmHg) | 3 months |
| 3 months |
| All-cause mortality | 3 months |