Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 4
- 主要终点
- total mortality
研究概览
简要总结
The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.
详细描述
The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:
- Four-hour dialysis session, blood flow rate 300-400 ml/min
- Eight-hours dialysis session, blood flow rate 200-250 ml/min
Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Older than 18-years
- •On maintenance bicarbonate HD scheduled thrice weekly 12 hours/week; achieved mean single pool Kt/V above 1.2
- •Willingness to participate in the study with a written informed consent
排除标准
- •To be scheduled for living donor renal transplantation
- •To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- •Pregnancy or lactating
- •Current requirement for HD more than three times per week due to medical comorbidity
- •GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
- •Use of temporary catheter
- •Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
- •Mental incompetence
结局指标
主要结局
total mortality
时间窗: one year
次要结局
- cardiovascular mortality(one year)
- changes in health-related quality of life, depression burden, cognitive function(one year)
- required medications(one year)
- total cost(one year)
- changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin(one year)
- hospitalization rate(one year)
- Vascular access patency(one year)
- post-dialysis body weight and total body water(one year)
- arrythmia episodes determined by Holter-ECG(one year)