Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Percent Brain Volume Change (PBVC)
研究概览
简要总结
The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.
The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.
Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Informed consent
- •Patient with end-stage renal disease (ESRD)
- •Stabile hemodialysis treatment (Kt/V ≥ 1.3)
- •No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity)
- •Weight <140kg
排除标准
- •Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study
- •Changes in corticosteroid treatment during the last two weeks
- •Change in diuretics during the last two weeks
- •Non-compliant with regard to salt and fluid intake
- •Acute disease
结局指标
主要结局
Percent Brain Volume Change (PBVC)
时间窗: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.
Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. Randomization determines the order of treatment (hemodialysis vs hemodiafiltration). MRI-data will later be processed to estimate the PBVC.
次要结局
未报告次要终点