HemoDiafiltration Versus HemoDialysis in OLDER People: a Randomized, Multicenter, Crossover, Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Change in dialysis recovery time
研究概览
简要总结
This study will compare the impact of two hemodialysis techniques on fatigue and post-dialysis recovery time in patients aged 85 years and older. These two techniques are high-flux hemodialysis (HD) and hemodiafiltration (HDF).
Patients will receive the treatment over two periods: if period 1 is HD then period 2 will be HDF. Every patient will be his/her own control, this is why it is called cross-over. Each period will last three months. Between the two periods, patients will receive a traditional low-flux hemodialysis.
These two techniques are widely used worldwide and their side-effects are well-known and do not put the patients at risk. HDF has been shown to improve survival in patients with a mean age of 58 years. But a previous study from the investigators' group showed that HDF causes a prolonged recovery time in older patients. This randomized trial aims to elucidate this question.
详细描述
Study purpose: To determine the best modality of hemodialysis in older patients > 84 years
Study Design: Randomized, multicenter, crossover, pragmatic clinical trial.
Eligible participants will be randomized in a 1:1 ratio for HDF or high-flux hemodialysis using a centralized, web-based randomization module integrated into the DATACAPT electronic case report form (eCRF). Allocation concealment will be ensured because the treatment assignment will only be generated after the patient has been enrolled and all eligibility criteria have been confirmed within the eCRF system.
Investigators and study personnel will not have access to the allocation sequence or block sizes prior to randomization.
Patients will be randomized to two sequences, each one of a 3-month period. Sequence 1 includes 3 months of hemodiafiltration (Period 1) then 3 months of high-flux hemodialysis (Period 2). Sequence 2 includes 3 months of high-flux hemodialysis (Period 1) then 3 months of hemodiafiltration (Period 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Data analysis
入排标准
- 年龄范围
- 85 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Age >84 years
- •Diagnosed with kidney failure
- •On maintenance hemodialysis >3months
- •Willing to have a dialysis session of 3.5 to 4-hour duration, three times a week
- •Has a reliable vascular access
- •Is covered by the health insurance
排除标准
- •Patients with cognitive impairment (assessed with a mini-test if needed)
- •Hospitalized at inclusion
- •Have difficulties with French speaking
- •Terminally ill with life expectancy<3 months
- •With active cancer
研究组 & 干预措施
Sequence 1: HD HDF
The patient will receive three months of HD followed by three months of HDF
干预措施: High-flux hemodialysis (Other)
Sequence 1: HD HDF
The patient will receive three months of HD followed by three months of HDF
干预措施: Hemodiafiltration (Other)
Sequence 2: HDF HD
The patient will receive three months of HDF followed by three months of HD
干预措施: High-flux hemodialysis (Other)
Sequence 2: HDF HD
The patient will receive three months of HDF followed by three months of HD
干预措施: Hemodiafiltration (Other)
结局指标
主要结局
Change in dialysis recovery time
时间窗: Three months
Time in minutes that the patient needs after dialysis to recover energy
次要结局
- Change in fatigue score(Three months)
- Change in STS-30(Three months)
- Change in SF-12 scores(Three months)
- Number of episodes of of symptomatic hypotension(Three months)
- Number of intradialytic clotting events(Three months)
- Change in serum albumin(Three months)
- Change in serum phosphate(Three months)
- Change in hemoglobin level(Three months)
- Change in serum potassium level(Three months)
- Change in Kt/V(Three months)
- Hospitalisation(From the start to the end of period 1 (HD) and from the start to the end of period 2 (HDF))
- Death(From the start to the end of period 1 (HD) and from the start to the end of period 2 (HDF))
研究者
Mabel Aoun
Nephrologist
AUB Santé