Potassium-Restricted Diet for Hyperkalemia

(EvoKe-HD Trial)

Overseen By Guylaine Marcotte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Disqualifiers: Life expectancy <6 months, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes for managing hyperkalemia.

Is a potassium-restricted diet safe for humans?

A potassium-restricted diet is generally considered safe for humans, especially for those with chronic kidney disease (CKD) who are at risk of hyperkalemia (high potassium levels in the blood). However, it's important to avoid potassium-rich foods and salt substitutes, as they can lead to hyperkalemia, which can cause serious heart problems. Always consult with a healthcare provider before making dietary changes. ^{1 2 3 4 5}

How does the potassium-restricted diet treatment for hyperkalemia differ from other treatments?

This treatment is unique because it focuses on reducing the intake of foods with highly bioavailable potassium, while maintaining necessary nutrients like fiber and alkali, which are important for overall health. Unlike other treatments that may involve medications, this approach emphasizes dietary education and cooking methods to manage potassium levels effectively. ^{1 2 6 7 8}

What data supports the effectiveness of a potassium-restricted diet for managing hyperkalemia?

Research indicates that managing potassium intake is crucial for patients with kidney disease, as hyperkalemia (high potassium levels) can be life-threatening. Adjusting dietary potassium has been shown to help control potassium levels, especially in children with chronic kidney disease, suggesting that a potassium-restricted diet could be effective in managing hyperkalemia. ^{1 2 5 6 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your blood test results showed high potassium levels at least two times in the past 3 months before dialysis.

I have been on hemodialysis 3 times a week for at least 3 months.

I can speak and understand either French or English.

Exclusion Criteria

The doctors don't think you will live longer than 6 months.

You do not have control over what you eat, for example if you live in a nursing home where your meals are chosen for you.

You have trouble understanding dietary recommendations due to a serious problem with thinking and remembering.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary counseling to manage potassium intake, with monthly meetings with a renal dietitian

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel dietary approach focused on restricting the intake of highly bioavailable potassium
• Traditional approach

Trial Overview 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.

How Is the Trial Designed?

Group I: Restriction high bioavailability potassium sources Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials

17

Recruited

4,600+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 212 patients with chronic kidney disease (CKD), dietary potassium intake was not associated with serum potassium levels or hyperkalemia, suggesting that potassium restriction may not be necessary for all patients.

Factors such as diabetes mellitus and metabolic acidosis were significant predictors of hyperkalemia, indicating that other clinical conditions should be considered when managing potassium levels in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does dietary potassium intake associate with hyperkalemia in patients with chronic kidney disease? Ramos, CI., González-Ortiz, A., Espinosa-Cuevas, A., et al.[2022]

In patients with chronic kidney disease (CKD), maintaining potassium (K+) balance is crucial to prevent hyperkalemia, and this is achieved through increased kidney and gastrointestinal excretion as long as the glomerular filtration rate (GFR) is above 15-20 mL/min.

Management strategies for hyperkalemia include reviewing and potentially discontinuing medications that impair K+ excretion, educating patients about dietary sources of potassium, and using diuretics and potassium-binding drugs to help maintain safe potassium levels while allowing the continued use of beneficial medications like renin-angiotensin blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathophysiology and clinical management of hyperkalemia in chronic kidney disease. Palmer, BF., Clegg, DJ.[2023]

Patients with reduced kidney function should limit their potassium intake to less than 3 g per day to prevent hyperkalaemia, while still maintaining a high fiber intake for overall health.

The paper suggests practical dietary interventions, such as educating patients about potassium-rich foods, using cooking methods to reduce potassium levels, and being aware of hidden potassium sources in processed foods, to help manage potassium intake effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. Cupisti, A., Kovesdy, CP., D'Alessandro, C., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

The dietary management of potassium in children with CKD stages 2-5 and on dialysis-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Potassium binding for conservative and preservative management of chronic kidney disease. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Review of case reports on hyperkalemia induced by dietary intake: not restricted to chronic kidney disease patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Does dietary potassium intake associate with hyperkalemia in patients with chronic kidney disease? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Dietary Potassium Restrictions in CKD on Clinical Outcomes: Benefits of a Plant-Based Diet. [2020]

7. Italy pubmed.ncbi.nlm.nih.gov

Pathophysiology and clinical management of hyperkalemia in chronic kidney disease. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Approach to Recurrent or Chronic Hyperkalaemia in Patients with Decreased Kidney Function. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Sodium-Reduced Meat and Poultry Products Contain a Significant Amount of Potassium from Food Additives. [2019]