A Randomized Controlled Study of Dialysis Less Frequently in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Days Alive and Out of Hospital
研究概览
简要总结
Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 70 or above
- •have developed end stage kidney disease and require hemodialysis treatment
排除标准
- •Hospitalized patients without an alternate level of care designation
- •Those with missed hemodialysis sessions due to non-adherence during the first 7 weeks of hemodialysis treatment
- •Patients already prescribed twice weekly hemodialysis
- •Patients who are medically unsuitable as per primary care team and site investigator
- •anticipated significant barriers to ascertainment of patient-reported experience measures
结局指标
主要结局
Days Alive and Out of Hospital
时间窗: 365 days
Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home.
次要结局
- Days Alive and Out of Hospital(2 years)
- Quality-adjusted life years(2 years)
- Change in Edmonton Symptom Assessment Scale-revised Renal score from baseline to average of all follow-up assessments(2 years)
- Change in Kidney Dialysis and Quality of Life-36 scores from baseline to average of all follow-up assessments(2 years)
- Clinical Frailty Scale score(2 years)
- Number of urgent unscheduled hemodialysis treatment for hyperkalemia(2 years)
- Number of urgent unscheduled hemodialysis treatment for volume overload(2 years)
- Weekly pre-hemodialysis potassium levels > 5.9 mmol/L(2 years)
- Change in urine volume(2 years)
- Hospitalization(2 years)
- Kidney function recovery(2 years)
- Elective withdrawal from hemodialysis treatment(2 years)
- Cost(2 years)
- Environmental costs attributed to hemodialysis treatment(2 years)
- mortality(2 years)
研究者
Dr. Christine White
Principal Investigator
Queen's University