Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 26
- 主要终点
- Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
研究概览
简要总结
HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Patients who give voluntary signed informed consent
- •Patients affiliated with the French universal health care system or similar
- •For women of childbearing potential: serum or urine negative pregnancy test
- •Patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment)
- •Bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture
- •Patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis)
排除标准
- •Pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months)
- •Patients not affiliated with the French universal health care system
- •Minor patients
- •Patients who are protected adults according to the terms of the law (French public health laws).
- •Refusal to give consent
- •Patients simultaneously participating in another trial that may interfere with the study results
结局指标
主要结局
Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
时间窗: Every 2 weeks during 3 months.
Definition of success: if during the period of daily hemodialysis at low dialysate flow, the patient maintains the absolute value of their pre-dialysis serum creatinine (mid-week dialysis) below the upper limit of the confidence interval established during the 3 months prior to inclusion on 7 values: measurements every 2 weeks for 3 months (retrospective data) and inclusion measurement included (Day 0). Daily hemodialysis at low dialysate flow will be considered as a failure if pre-dialysis serum creatinine values exceed twice successively the upper limit of the confidence interval established for the patient.
次要结局
- Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.(3 months.)
- Evaluation of heart rate.(During 3 months (retrospectively and prospectively).)
- Evaluation of inflammation parameters.(During 3 months (retrospectively and prospectively).)
- Evaluation of iron parameters.(During 3 months (retrospectively and prospectively).)
- Change in hormones.(At inclusion and at 3 months.)
- Evaluation of body mass index.(During 3 months (retrospectively and prospectively).)
- Composite measurement of technical dialysis parameters.(During 3 months (retrospectively and prospectively).)
- Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).(3 months.)
- Evaluation of weight.(During 3 months (retrospectively and prospectively).)
- Evaluation of blood pressure.(During 3 months (retrospectively and prospectively).)
- Evaluation of metabolic parameters.(During 3 months (retrospectively and prospectively).)
- Evaluation of hematological parameters.(During 3 months (retrospectively and prospectively).)
- Evaluation of nutrition parameters.(During 3 months (retrospectively and prospectively).)
- Composite measurement of treatments.(During 3 months (retrospectively and prospectively).)
- List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications.(At each hemodialysis during 3 months (retrospectively and prospectively).)
- Change in quality of life.(At inclusion and at 3 months.)
- Change in pain.(At inclusion and at 3 months.)