Potassium-Restricted Diet for Hyperkalemia

(EvoKe-HD Trial)

Recruiting at 1 trial location

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?

This trial tests a new method for managing hyperkalemia, a condition characterized by excessive potassium in the blood. Instead of eliminating all high-potassium foods, the focus is on avoiding foods with easily absorbed potassium, such as processed meats and certain drinks. This novel dietary approach is compared to the traditional method. Participants are divided into two groups: one avoids these specific foods, while the other reduces high-potassium foods overall. Suitable candidates for this trial include those on dialysis three times a week who have experienced high potassium levels before treatments. As an unphased trial, this study provides a unique opportunity to explore innovative dietary management strategies for hyperkalemia.

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.

What prior data suggests that this dietary approach is safe for managing hyperkalemia?

Research has shown that high potassium intake can sometimes increase the risk of hyperkalemia in people with chronic kidney disease (CKD). For this reason, doctors often recommend reducing foods high in potassium. However, some studies have found no link between dietary potassium intake and blood potassium levels, suggesting that consuming potassium-rich foods might not always lead to elevated potassium levels in the body.

While specific safety studies on this new dietary approach are lacking, it generally remains safe for most people since it involves dietary changes. Avoiding foods like processed meats and sugary drinks may even provide additional health benefits. It is important to consult a healthcare provider before making significant dietary changes, especially if other health issues are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh dietary approach to managing hyperkalemia, a condition characterized by high potassium levels in the blood. Unlike traditional methods that simply cut down on foods with high total potassium, this new approach focuses on restricting foods with highly bioavailable potassium, such as those with potassium additives and certain animal products. This could offer a more targeted way to manage potassium levels by reducing the intake of potassium that is more readily absorbed by the body. The trial aims to determine if this method is more effective and easier for patients to follow compared to conventional dietary restrictions.

What evidence suggests that this trial's dietary approaches could be effective for hyperkalemia?

Studies have shown that controlling potassium intake is crucial for individuals with high potassium levels, particularly those with chronic kidney disease (CKD). In this trial, participants will follow one of two dietary approaches. The traditional approach reduces foods high in total potassium content, such as fruits and vegetables. The novel dietary approach, assigned to some participants, avoids foods where potassium is easily absorbed, including those with additives, processed meats, milk, and sugary drinks. Research indicates that this method may better manage potassium levels. Although more research is needed, this approach could offer a promising way to improve health for people with high potassium levels. ^{6 7 8 9 10}

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 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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10872890/

New Insights Into Dietary Approaches to Potassium ... Potassium disorders are one of the most common electrolyte abnormalities in patients with chronic kidney disease (CKD), contributing to poor clinical outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051227624000591

Evaluating the Effectiveness of a Generative Pretrained ... This study aims to evaluate the effectiveness of a dietary recommendation system driven by generative pretrained transformers (GPTs) in managing potassium ...

3. withpower.com withpower.com/trial/phase-hyperkalemia-2024-25460

Potassium-Restricted Diet for Hyperkalemia (EvoKe-HD Trial) EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia.

4. aafp.org aafp.org/pubs/afp/issues/2023/0100/potassium-disorders-hypokalemia-hyperkalemia.html

Potassium Disorders: Hypokalemia and Hyperkalemia A low-potassium diet is generally recommended for patients with advanced CKD (Table 2). More research is needed for dietary potassium restriction in CKD.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051227621001758

Effect of Dietary Potassium Restriction on Serum ... Very-low-quality evidence supports consensus that dietary potassium restriction reduces Sk in normokalemia but whether this is associated with risk of death in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7406842/

Impact of Dietary Potassium Restrictions in CKD on Clinical ... There are data suggesting that high-potassium intake increases the risk for hyperkalemia in some patients with CKD, and current recommendations and guidelines ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10780359/

Re-Thinking Hyperkalaemia Management in Chronic ... Lower dietary potassium intake was associated with higher risk of death (HR 2.65, 95% CI 1.40–5.04) in fully adjusted model comparing lowest ...

8. jrnjournal.org jrnjournal.org/article/S1051-2276(22)00212-6/fulltext

New Insights Into Dietary Approaches to Potassium ... In this study, the researchers found no association of dietary potassium intake with serum potassium levels, with prevalence of hyperkalemia, or ...

9. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1285929/full

Overview of research progress on the association of dietary ... This study showed no association between serum potassium and dietary potassium intake in the low potassium intake(≤3000 mg/d) and high potassium intake(>3000 mg ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105122762400058X

Associations Between Dietary Potassium Intake From ... This study investigated the association between potassium intake from different food sources and hyperkalemia in patients with non-dialysis-dependent CKD.