A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable.
This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD.
- •Patients have to be on chronic HD for at least 2 months before eligibility
排除标准
- •Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months
- •Patients scheduled to be switched to peritoneal dialysis in the next 6 months
- •Patients currently receiving >3 days per week of hemodialysis
- •Patients currently receiving >12 hours per week of hemodialysis
- •Anyone <3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg
- •Patients >21 years of age at enrollment
- •Patients receiving concomitant peritoneal dialysis
- •Patients with <2 months on chronic HD
- •Patients with a temporary or femoral dialysis catheter
- •Patients who are not hypertensive (both not on blood pressure medication and with a SBP <95th percentile for age, sex, and height)
- •Patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study
- •Patients listed for a deceased donor transplant will not be excluded.
结局指标
主要结局
Systolic Blood Pressure
时间窗: up to 24 weeks
次要结局
- Treatment Costs(up to 24 weeks)
- Quality of Life(up to 24 weeks)
- Adverse Events/Symptoms(up to 24 weeks)
- Anemia(up to 24 weeks)
- Nutrition and Growth(up to 24 weeks)
- Diastolic Blood Pressure(up to 24 weeks)
- Bone Health(up to 24 weeks)
- Echocardiogram measured left ventricular mass(every 3 months)
- School Performance(every 3 months)
- Inflammatory Markers(every 3 months)