Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperkalemia, Diminished Renal Excretion
• Intervention / Treatment: Behavioral: Novel dietary approach focused on restricting the intake of highly bioavailable potassium; Behavioral: Traditional approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelie Bernier-Jean; Phone Number: 514 338-2883; Email: amelie.jean-bernier@umontreal.ca
• Study Contact Backup: Name: Guylaine Marcotte; Phone Number: 3182 514 338-2222; Email: guylaine.marcotte.cnmtl@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4J 1C5
      • CIUSSS du Nord-de-l'Île-de-Montréal
      • Contact: Guylaine Marcotte; Phone Number: 3182 514-338-2222; Email: guylaine.marcotte.cnmtl@ssss.gouv.qc.ca
      • Principal Investigator: Amélie Bernier-Jean, PhD
      • Sub-Investigator: Rémi Goupil, MD
      • Sub-Investigator: François Madore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restriction high bioavailability potassium sources; 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 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.
Active Comparator: Control; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of prevalent dialysis patients recruited and retained for 6 months	Primary feasibility outcome	6 months
Change in average mid-week predialysis potassium level during the study period		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight (kg)		6 months
Ratio of the number of randomized participants over the number of screened participants randomized	Secondary feasibility outcome	6 months
Number of participants recruited 12 months into the trial	Secondary feasibility outcome	6 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	6 months
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors	Secondary feasibility outcome	6 months
Average monthly midweek pre-dialysis serum potassium level (mmol/L)		6 months
Peak serum potassium over the study period		6 months
Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events		6 months
Number of dialysis sessions with dialysate concentration < 2mmol/L		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
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.	6 months
Mediterranean diet score	0 to 100 score; higher score represents a better adherence to the Mediterranean diet	6 months
Mediterranean-diet scale	Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence)	6 months
Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)		6 months
Number of servings/day of moderate to high total potassium food items		6 months
Ratio of plant to animal protein intake (g/g)		6 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.	6 months
Albumin levels (g/L)		6 months
Pre-albumin levels (g/L)		6 months
Normalized protein nitrogen appearance (g/kg/day)	calculated from urea reduction ratio	6 months
Body mass index (kg/m2)		6 months
Satisfaction with food-related life	5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food	6 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)	6 months
Self-perceived compliance with the dietary recommendations	"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors)	6 months
Average monthly midweek pre-dialysis serum phosphate level (mmol/L)		6 months
Average monthly midweek pre-dialysis serum calcium level (mmol/L)		6 months
Pre-dialysis serum parathyroid hormone level (pmol/L)		6 months
Monthly average serum bicarbonate levels (mmol/L)		6 months
1-week average inter-dialytic weight gain (kg/day)		6 months
1-week average pre dialysis blood pressure (mmHg)		6 months
1-week average post dialysis blood pressure (mmHg)		6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		6 months
Major cardiovascular events	Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	6 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)	6 months

Collaborators and Investigators

• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
• Collaborators: Canadian Institutes of Health Research (CIHR)

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; Hemodialysis; Potassium; Hyperkalemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: Pending (Pending)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No