Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration: A Pragmatic Cluster-randomized Clinical Trial in Hemodialysis Centres
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Composite outcome of cardiovascular-related hospitalization and all-cause mortality
研究概览
简要总结
Many patients on hemodialysis have low levels of magnesium. Magnesium is needed to keep the heart, kidneys, and other organs working properly. Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet, medication interference, and the dialysis procedure itself, which leaches small amounts of magnesium from the blood during each treatment.
One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate. The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues. The investigator thinks increasing the magnesium in the dialysate will help patients live longer, have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis.
This simple adjustment to the dialysis procedure can be done at little to no cost and may even reduce overall healthcare costs. If the investigator can show that increasing magnesium in the dialysate improves patients' health, then it could become the standard of care for dialysis centres.
详细描述
- Statement of the health problem or issue
In end-stage kidney disease, dialysis is needed to remove toxins and electrolytes that would otherwise accumulate in a patient's blood. The fluid used in dialysis, the dialysate, contains magnesium, and the lower the concentration of dialysate magnesium, the more magnesium is removed from a patient's body during dialysis. Understanding the optimal amount of magnesium to include in the dialysate is crucial as magnesium regulates more than 300 enzymes in the body and is vital to heart, muscle, and bone health.
In Canada, the dialysate is prepared by central suppliers and contains magnesium in concentrations of 0.38, 0.5, or 0.75 mmol/L. In the absence of clinical trial evidence, there is no consensus on what magnesium concentration is best, and all 3 concentrations are used today in Canadian hemodialysis centres. 2. Objective of the project
In outpatients receiving conventional hemodialysis, to determine if providing a higher versus lower dialysate magnesium concentration (0.75 vs. ≤0.5 mmol/L) as a centre policy alters outcomes important to patients and their providers. 3. Outline
This is a pragmatic, two-arm, parallel-group, cluster-randomized, open-label, multicentre, comparative-effectiveness trial embedded into routine care in hemodialysis centres in Canada. Centres have been randomized to, and are receiving a dialysate magnesium concentration of 0.75 mmol/L or ≤0.5 mmol/L in the intervention and control groups, respectively. Patients receiving maintenance hemodialysis at these centres will be followed for study outcomes during the trial follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Inclusion (Hemodialysis Center Level):
- •The hemodialysis center must be expected to treat at least 15 different individuals with facility-based maintenance hemodialysis over the trial period.
- •The hemodialysis center must use a system permitting the adoption of the randomly allocated dialysate Mg concentration (e.g., centers using BiCart® dialysate products, which do not include a dialysate Mg concentration of 0.75 mmol/L, were not eligible to participate).
- •The medical director, in consultation with local partners, must approve the randomization of their center and the adoption of the allocated dialysate Mg concentration as a center-wide policy for the trial period.
排除标准
- •The centre, or group of hemodialysis centres cares for less than 15 patients being treated with conventional in-centre hemodialysis.
研究组 & 干预措施
Lower dialysate magnesium
干预措施: Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L). (Other)
Higher dialysate magnesium
干预措施: Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L). (Other)
结局指标
主要结局
Composite outcome of cardiovascular-related hospitalization and all-cause mortality
时间窗: Three to Four Years
Cardiovascular-related hospitalization (for myocardial infarction, ischemic stroke, or congestive heart failure) will be ascertained using primary discharge ICD-10 diagnosis codes in the Canadian Institute for Health Information's Discharge Abstract Database. All-cause mortality is recorded with over 99% accuracy in our data sources.
A composite of all-cause mortality or major cardiovascular-related hospitalizations
时间窗: Four Years
Data on all-cause mortality will be ascertained using provincial vital statistics databases. Major cardiovascular-related hospitalization (for myocardial infarction, ischemic stroke, or congestive heart failure) will be ascertained using most responsible diagnosis ICD-10 codes in the Canadian Institute for Health Information's Discharge Abstract Database.
Self-reported muscle cramps
时间窗: Four years
Self-reported muscle cramps. For self-reported muscle cramps patients will be able to voluntarily and anonymously answer a question on muscle cramps to describe on average how much this symptom bothered them in the past week. Responses will be recorded on a 11-point scale, with 0 indicating absence of the symptom and 10 indicating the symptom is at its worst. The question will be made available in the dialysis centre approximately twice a year. No patient identifiers will be collected, and this outcome will be assessed at the level of the centre. Data from the Spring 2026 collection period will be used in the primary analysis
次要结局
- Components of the primary composite outcome(Three to Four Years)
- Key secondary outcome - patient-reported muscle cramps(Three to Four Years)
- All-cause mortality(Four Years)
- Major cardiovascular-related hospitalization(Four years)