Clinical trial NCT06120608: Evidence for Potassium Restriction in Hemodialysis
Official title: Evidence for Potassium Restriction in Hemodialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperkalemia, Diminished Renal Excretion
Keywords: Potassium
Hyperkalemia
Hemodialysis
Nutrition
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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
* 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.

Primary outcomes:
measure: Percentage of prevalent dialysis patients recruited and retained for 6 months
timeFrame: 6 months
measure: Change in average mid-week predialysis potassium level during the study period
timeFrame: 6 months
Secondary outcomes:
measure: Ratio of the number of randomized participants over the number of screened participants randomized
timeFrame: 6 months
measure: Number of participants recruited 12 months into the trial
timeFrame: 6 months
measure: Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors
timeFrame: 6 months
measure: Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
timeFrame: 6 months
measure: Average monthly midweek pre-dialysis serum potassium level (mmol/L)
timeFrame: 6 months
measure: Peak serum potassium over the study period
timeFrame: 6 months
measure: Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events
timeFrame: 6 months
measure: Number of dialysis sessions with dialysate concentration < 2mmol/L
timeFrame: 6 months
measure: Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)
timeFrame: 6 months
measure: Total dose of potassium binders (g) over the study period
timeFrame: 6 months
measure: Number of participants taking potassium binders at 6 months
timeFrame: 6 months
measure: Healthy diet index 2020
timeFrame: 6 months
measure: Mediterranean diet score
timeFrame: 6 months
measure: Mediterranean-diet scale
timeFrame: 6 months
measure: Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)
timeFrame: 6 months
measure: Number of servings/day of moderate to high total potassium food items
timeFrame: 6 months
measure: Ratio of plant to animal protein intake (g/g)
timeFrame: 6 months
measure: Subjective global assessment
timeFrame: 6 months
measure: Albumin levels (g/L)
timeFrame: 6 months
measure: Pre-albumin levels (g/L)
timeFrame: 6 months
measure: Normalized protein nitrogen appearance (g/kg/day)
timeFrame: 6 months
measure: Body mass index (kg/m2)
timeFrame: 6 months
measure: Change in weight (kg)
timeFrame: 6 months
measure: Satisfaction with food-related life
timeFrame: 6 months
measure: Self-perceived impact on diet
timeFrame: 6 months
measure: Self-perceived compliance with the dietary recommendations
timeFrame: 6 months
measure: Average monthly midweek pre-dialysis serum phosphate level (mmol/L)
timeFrame: 6 months
measure: Average monthly midweek pre-dialysis serum calcium level (mmol/L)
timeFrame: 6 months
measure: Pre-dialysis serum parathyroid hormone level (pmol/L)
timeFrame: 6 months
measure: Monthly average serum bicarbonate levels (mmol/L)
timeFrame: 6 months
measure: 1-week average inter-dialytic weight gain (kg/day)
timeFrame: 6 months
measure: 1-week average pre dialysis blood pressure (mmHg)
timeFrame: 6 months
measure: 1-week average post dialysis blood pressure (mmHg)
timeFrame: 6 months
Other outcomes:
measure: Major cardiovascular events
timeFrame: 6 months
measure: Standardised Outcomes in NephroloGy fatigue measure
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
Locations:
city: Montréal
country: Canada
facility: CIUSSS du Nord-de-l'Île-de-Montréal
state: Quebec
Study officials:
References: