NCT03487146已完成不适用
Hemoperfusion in Combination With Hemodialysis for Improvement of Self-reported Sleep Disturbance and Overall Survival Rate in Maintenance Hemodialysis Patients
Shanghai Pudong Hospital0 个研究点目标入组 156 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 主要终点
- improvement of self-reported sleep disturbance
研究概览
简要总结
Sleep disturbance has been long-standing torments in most of patients with maintenance hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion (HP) could improve sleep disorder and increase overall survival rate in HD 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of maintenance HD should be equal or more than 3 months,
- •patient's age should be equal or more than 18 years
排除标准
- •i) he/she diagnosed with malignant tumors, an active rheumatism, infectious diseases, or a severe heart failure ii) he/she would disagree with the study
- •he/she has received a short-term poor prognosis
- •he/she would be more than 80 years old
研究组 & 干预措施
HD(hemodialysis) group
No Intervention
HD group as conventional control arm
HD+HP(hemodialysis+hemoperfusion) group
Active Comparator
HD+HP as active interventional group.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.
干预措施: hemoperfusion(HP) (Device)
结局指标
主要结局
improvement of self-reported sleep disturbance
时间窗: 2 years
Analysis of the sleep disturbance by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
次要结局
- survival(2 years)
研究者
Jin HM, MD
Professor
Shanghai Pudong Hospital
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