Status:
ACTIVE_NOT_RECRUITING
Evidence for Potassium Restriction in Hemodialysis
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hyperkalemia, Diminished Renal Excretion
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 counsell...
Eligibility Criteria
Inclusion
- ≥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 OR the most recent pre-dialysis serum potassium value ≥ 4.6 mmol/L and is currently prescribed a potassium-binding agent at a regular frequency (defined as ≥ once per week).
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 12 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06120608
Start Date
June 17 2025
End Date
March 12 2026
Last Update
December 16 2025
Active Locations (1)
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1
CIUSSS du Nord-de-l'Île-de-Montréal
Montreal, Quebec, Canada, H4J 1C5