Evidence for Potassium Restriction in Hemodialysis (EvoKe-HD) Pilot Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of prevalent dialysis patients recruited and retained for 3 months
研究概览
简要总结
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.
详细描述
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 counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last three months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study.
The study will be successful if 30% or more of the eligible patients agree to participate and complete the 3-month assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
结局指标
主要结局
Percentage of prevalent dialysis patients recruited and retained for 3 months
时间窗: 3 months
Primary feasibility outcome
Change in average mid-week predialysis potassium level during the study period
时间窗: 3 months
次要结局
- Ratio of the number of randomized participants over the number of screened participants randomized(3 months)
- Satisfaction with food-related life(3 months)
- Number of participants recruited 12 months into the trial(3 months)
- Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors(3 months)
- Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors(3 months)
- Average monthly midweek pre-dialysis serum potassium level (mmol/L)(3 months)
- Peak serum potassium over the study period(3 months)
- Number of hyperkalemia (≥5.6 mmol/L) and severe hyperkalemia (>6 mmol/L) events(3 months)
- Number of dialysis sessions with dialysate concentration < 2mmol/L(3 months)
- Number of patients for whom the potassium dialysate concentration was raised or lowered (by ≥0.5mmol/L)(3 months)
- Total dose of potassium binders (g) over the study period(3 months)
- Number of participants taking potassium binders at 3 months(3 months)
- Healthy diet index 2020(3 months)
- Mediterranean diet score(3 months)
- Mediterranean-diet scale(3 months)
- Number of servings/day of high potassium bioavailability items (meat, dairy, juices, potatoes)(3 months)
- Number of servings/day of moderate to high total potassium food items(3 months)
- Ratio of plant to animal protein intake (g/g)(3 months)
- Subjective global assessment(3 months)
- Albumin levels (g/L)(3 months)
- Normalized protein nitrogen appearance (g/kg/day)(3 months)
- Body mass index (kg/m2)(3 months)
- Change in weight (kg)(3 months)
- Self-perceived impact on diet(3 months)
- Self-perceived compliance with the dietary recommendations(3 months)
- Average monthly midweek pre-dialysis serum phosphate level (mmol/L)(3 months)
- Average monthly midweek pre-dialysis serum calcium level (mmol/L)(3 months)
- Pre-dialysis serum parathyroid hormone level (pmol/L)(3 months)
- Monthly average serum bicarbonate levels (mmol/L)(3 months)
- Inter-dialytic weight gain (kg/day)(3 months)
- 1-week average pre dialysis blood pressure (mmHg)(3 months)
研究者
Amélie Bernier-Jean
Clinical Associate Professor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal