Evidence for Potassium Restriction in Hemodialysis
- Conditions
- Hyperkalemia, Diminished Renal Excretion
- Interventions
- Behavioral: Traditional approachBehavioral: Novel dietary approach focused on restricting the intake of highly bioavailable potassium
- Registration Number
- NCT06120608
- Lead Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- 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 six 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 6-month assessment.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- ≥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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control 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. Restriction high bioavailability potassium sources 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.
- Primary Outcome Measures
Name Time Method Change in average mid-week predialysis potassium level during the study period 6 months Percentage of prevalent dialysis patients recruited and retained for 6 months 6 months Primary feasibility outcome
- Secondary Outcome Measures
Name Time Method Ratio of plant to animal protein intake (g/g) 6 months Subjective global assessment 6 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.
Self-perceived compliance with the dietary recommendations 6 months "I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)
Average monthly midweek pre-dialysis serum calcium level (mmol/L) 6 months Number of participants recruited 12 months into the trial 6 months Secondary feasibility outcome
Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors 6 months Secondary feasibility outcome
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors 6 months Secondary feasibility outcome
Number of dialysis sessions with dialysate concentration < 2mmol/L 6 months Mediterranean-diet scale 6 months Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes) 6 months Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L) 6 months Total dose of potassium binders (g) over the study period 6 months Number of participants taking potassium binders at 6 months 6 months Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events 6 months Healthy diet index 2020 6 months Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100.
Peak serum potassium over the study period 6 months Albumin levels (g/L) 6 months Pre-albumin levels (g/L) 6 months Body mass index (kg/m2) 6 months Pre-dialysis serum parathyroid hormone level (pmol/L) 6 months 1-week average inter-dialytic weight gain (kg/day) 6 months Ratio of the number of randomized participants over the number of screened participants randomized 6 months Secondary feasibility outcome
Average monthly midweek pre-dialysis serum potassium level (mmol/L) 6 months Mediterranean diet score 6 months 0 to 100 score; higher score represents a better adherence to the Mediterranean diet
Number of servings/day of moderate to high total potassium food items 6 months Change in weight (kg) 6 months Self-perceived impact on diet 6 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)
Normalized protein nitrogen appearance (g/kg/day) 6 months calculated from urea reduction ratio
Satisfaction with food-related life 6 months 5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food
Average monthly midweek pre-dialysis serum phosphate level (mmol/L) 6 months 1-week average pre dialysis blood pressure (mmHg) 6 months 1-week average post dialysis blood pressure (mmHg) 6 months Monthly average serum bicarbonate levels (mmol/L) 6 months
Trial Locations
- Locations (1)
CIUSSS du Nord-de-l'Île-de-Montréal
🇨🇦Montréal, Quebec, Canada