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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

EvoKe-HD Trial 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.Check my eligibility

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.See study design

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.

EvoKe-HD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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I have missed no more than one dialysis session in the last 3 months.

EvoKe-HD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in average mid-week predialysis potassium level during the study period

Percentage of prevalent dialysis patients recruited and retained for 6 months

Secondary outcome measures

1-week average inter-dialytic weight gain (kg/day)

1-week average post dialysis blood pressure (mmHg)

1-week average pre dialysis blood pressure (mmHg)

+30 more

Other outcome measures

All-cause mortality

Major cardiovascular events

Standardised Outcomes in NephroloGy fatigue measure

EvoKe-HD 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.

0 / 3Eligibility criteria met

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

12 Previous Clinical Trials

4,281 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,653 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial still open to new participants?

"Contrary to popular belief, this clinical trial is no longer actively seeking participants. Initially posted on January 1st 2024 and most recently updated on November 4th 2023, the study has since been closed off for recruitment. However, there are currently 20 other trials open for enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evidence for Potassium Restriction in Hemodialysis

Amélie Bernier-Jean 2024. "Evidence for Potassium Restriction in Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120608.