Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Result of the questionnaire "recovery time after a dialysis session"
研究概览
简要总结
In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described.
More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. The recovery time and quality of life of patients who will use a polyethersulfone membrane (Revaclear®) and a Medium Cut-Off (MCO) membrane (Theranova®) will be observed.
The main objective is to describe the evolution of recovery time after a dialysis session in conventional hemodialysis (HD) on Revaclear® membrane and in so-called optimized hemodialysis (HDx) on MCO membrane, Theranova®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age
- •Patient on conventional hemodialysis with synthetic membrane for at least 3 months
- •Patient with a recovery time after the dialysis session ≥ 4 hours
- •Informed patient who has signed a written consent to participate in the study
- •Affiliated patient or beneficiary of a social security scheme
排除标准
- •Patient whose seniority of dialysis is less than 3 months
- •Pregnant woman
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Patient with severe cognitive impairment
- •Medically unstable or frail patient
- •Patient who did not sign an informed consent form accepting this research (refusal of consent or absence of signature).
研究组 & 干预措施
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: Optimized hemodialysis (Procedure)
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: Questionnaire "recovery time after a dialysis session". (Other)
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: SF-12 questionnaire (Other)
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: EQ-5D-5L Questionnaire (Other)
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: Pittman, John et McIntyre questionnaire (Other)
Patient on conventional hemodialysis then on optimized hemodialysis
干预措施: Conventional hemodialysis (Procedure)
结局指标
主要结局
Result of the questionnaire "recovery time after a dialysis session"
时间窗: 7 months
only one question : how long time recovering after a dialysis session (hours)
次要结局
未报告次要终点