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Behavioral Intervention

Potassium-Restricted Diet for Hyperkalemia (EvoKe-HD Trial)

N/A
Waitlist Available
Research Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving hemodialysis 3 times/week for ≥ 3 months
≥18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will assess a dietary approach to reducing high potassium levels in the body, including foods with high bioavailable potassium.

Who is the study for?
This trial is for adults who speak French or English, have had at least two high potassium blood tests in the last 3 months, and regularly attend hemodialysis sessions. It's not for those with limited control over their diet, a life expectancy under six months, or significant cognitive issues.
What is being tested?
The EvoKe-HD study is testing a new dietary method to manage high potassium levels by limiting foods with easily absorbed potassium versus the traditional approach of avoiding high-potassium whole foods.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include nutritional deficiencies or imbalances if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on hemodialysis 3 times a week for at least 3 months.
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I am 18 years old or older.
Select...
I have missed no more than one dialysis session in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of prevalent dialysis patients recruited and retained for 6 months
Secondary study objectives
Healthy diet index 2020
Mediterranean diet score
Mediterranean-diet scale
+9 more
Other study objectives
Major cardiovascular events
Standardised Outcomes in NephroloGy fatigue measure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Restriction high bioavailability potassium sourcesExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
14 Previous Clinical Trials
4,504 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,519,182 Total Patients Enrolled
~40 spots leftby Dec 2026
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