Major Outcomes With Personalized Dialysate TEMPerature: Pragmatic, Registry-Based, Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Composite outcome of cardiovascular-related mortality or major cardiovascular event
研究概览
简要总结
People with failed kidneys need an artificial kidney machine (called dialysis) to remove toxins and extra fluid from the body. Most patients receive dialysis treatments at a hospital three times a week. During treatment, a patient's blood pressure may drop, causing dizziness and muscle cramping. Repeated drops in blood pressure can also injure the heart and brain. Over time, this can lead to heart attacks, strokes, and sometimes death due to cardiovascular causes. New research shows that cooling the temperature of the dialysis fluid (called dialysate) can reduce heart and brain injury. In most hospitals, all patients' dialysate temperature is set at 36.5 ºC (to match body temperature). In a study of 73 patients, we showed that reducing the dialysate temperature by 0.5 ºC below body temperature protected the heart and brain from injury [1,2]. We now want to test this simple, safe, low-cost intervention in a large study with ~7500 dialysis patients in Ontario. We can lower the dialysate temperature on dialysis machines in Ontario at no added cost. This intervention has the potential to reduce many hospitalizations and deaths in Ontario, and relieve suffering in patients with kidney failure.
详细描述
- Statement of the health problem or issue
Dialysis is a life-saving treatment for patients with kidney failure. However, over 20% of patients die within one year of starting dialysis from heart disease or stroke.
One reason that so many dialysis patients die from heart diseases and strokes may be related to the dialysis treatment itself. During dialysis, blood pressure often drops, and the flow of blood and oxygen to the heart and brain is reduced. Over time, this can cause significant damage to vital organs and result in heart attacks, strokes, and even death due to cardiovascular-related causes.
Our team was the first to show that the heart and brain become starved of blood and oxygen during dialysis. We and others have shown that lowering the temperature of dialysis (to just below the patient's own body temperature) improves blood flow and protects the heart and brain during dialysis. We will now determine if this method can prevent heart attacks and strokes in a large population of dialysis patients. 2. Objective of your project
The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations. 3. How will you undertake your work?
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The hemodialysis centre must have cared for a minimum of 15 outpatients being treated with maintenance in-centre hemodialysis on January 1st,
- •The medical director of the hemodialysis centre (who acted as the centre's gatekeeper) must have been willing for their centre to adopt the randomly allocated dialysate temperature protocol for the duration of the trial.
排除标准
- •The centre cares for less than 15 patients being treated with conventional in-centre hemodialysis.
结局指标
主要结局
Composite outcome of cardiovascular-related mortality or major cardiovascular event
时间窗: Four Years
There are many challenges associated with selecting the primary endpoint in MyTEMP because of heterogeneity of the population, complexity of renal pathophysiology and its interaction with cardiovascular disease, and competing risks of non-cardiovascular-related death. Our primary outcome is a composite outcome of cardiovascular-related mortality or a hospitalization for non-fatal major cardiovascular event which is any of myocardial infarction, ischemic stroke, or congestive heart failure. We chose a cause-specific death (i.e. cardiovascular) in our endpoint, in contrast to all-cause mortality, because non-cardiovascular causes of death are common in the hemodialysis population and the intervention is less likely to reduce the rate of such deaths. However, as a secondary outcome (see Secondary outcomes), we will also test the effect of personalized temperature-reduced dialysate temperature on all-cause mortality.
次要结局
- All-cause mortality(Four Years)
- Composite outcome of all-cause mortality or major cardiovascular event(Four Years)
- Key secondary outcome: Between-group mean difference in the intradialytic drop of systolic blood pressure.(Four Years)
- Hospitalization for non-fatal myocardial infarction(Four Years)
- Hospitalization for non-fatal congestive heart failure(Four Years)
- Hospitalization for non-fatal ischemic stroke(Four Years)
- Cardiovascular-related mortality(Four Years)