Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,846
- 试验地点
- 1
- 主要终点
- Death from any cause
研究概览
简要总结
OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease.
II. Compare the efficacy of high versus low flux dialyzer membranes.
详细描述
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation.
Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics.
Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted.
The intervention phase of this study is 5 years. Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •End stage renal disease that requires in-center hemodialysis 3 times/week On hemodialysis for at least 3 months (6 months following renal transplant)
- •No scheduled renal transplant from living donor
- •-Prior/Concurrent Therapy--
- •No concurrent intervention studies unless ancillary to this protocol No concurrent investigational drugs
- •-Patient Characteristics--
- •Hepatic: Albumin at least 2.6 g/dL by nephelometry No cirrhosis with encephalopathy or abnormal PT
- •Renal: Urea clearance (interdialytic) no greater than 1.5 mL/min per 35 liters total urea volume
- •Cardiovascular: No New York Heart Association class IV congestive heart failure despite maximal therapy No unstable angina No new onset angina No recent exacerbation of frequency, duration, or severity of angina
- •Pulmonary: No chronic pulmonary disease requiring supplemental oxygen
- •Other: Not hospitalized in acute or long term care facility at entry No active malignancy requiring chemotherapy or radiotherapy No AIDS No active systemic infection, e.g., tuberculosis or fungal infection No mental incompetence or other contraindication to protocol therapy Not pregnant Geographically available for treatment at participating institution No more than 20 missed treatments/year
排除标准
- 未提供
研究组 & 干预措施
High dose, high flux hemodialysis
干预措施: High dose, high flux hemodialysis (Device)
Standard dose, low flux hemodialysis
干预措施: Standard dose, low flux hemodialysis (Device)
Standard dose, high flux hemodialysis
干预措施: Standard dose, high flux hemodialysis (Device)
High dose, low flux hemodialysis
干预措施: High dose, low flux hemodialysis (Device)
结局指标
主要结局
Death from any cause
时间窗: 5 years
次要结局
- All hospitalizations not related to vascular access(5 years)
- Death due to cardiac causes(5 years)
- First hospitalization or death due to cardiac causes(5 years)
- Death due to infection(5 years)
- First >15% decrease in albumin or death from any cause(5 years)
- First hospitalization for cardiac causes or death from any cause(5 years)
- First hospitalization for infection or death from any cause(5 years)
- First hospitalization or death due to infection(5 years)