Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Total peripheral resistance index (TPRI)
研究概览
简要总结
Patients treated with hemodialysis (HD) bear increased risk of cardiovascular events, which results in high morbidity and mortality among this cohort of patients. Intradialytic hypotension (IDH), which is an independent risk factor for mortality, occurs in up to 20% of hemodialysis session and may lead to myocardial stunning and cerebral ischemia resulting in increased white matter lesions, gastrointestinal ischemia and shunt vessel thrombosis. Due to the deleterious effects of IDH during HD, preventive measurements such as limiting interdialytic weight gain are recommended, but frequently fluid and salt restriction are not adhered to, thus increasing dialysis time or frequency of treatments is a common strategy in those patients.
详细描述
A KDIGO (Kidney Disease: Improving Global Outcomes) controversies conference suggested that isolated ultrafiltration (iso-UF) may provide a benefit in hemodynamic stability, but whether this translates into benefits in hard outcomes is unclear and requires further research. So called-sequential dialysis, that is, isolated ultrafiltration followed by HD is commonly recommended, but evidence is very limited and mainly based on small older studies.
In conclusion, the supposed benefit for intradialytic hemodynamic stability attributed to isolated ultrafiltration compared to hemodialysis seems to be due to less pronounced changes in vascular resistance, but the reason for this discrepancy is unclear. Thus far, recommendations for using iso-UF to improve hemodynamic stability are mainly based on old studies which may not be applicable to modern technique used nowadays. Furthermore, there is no standardized approach on how to use isolated ultrafiltration, with neither a time period nor ultrafiltration rate recommended by the guidelines.
In this study, the investigators try to assess changes in peripheral resistance, osmolality, cardiac output, and cardiac power index and try to establish exploratory correlations to IDH episodes. Furthermore, the investigators want to assess the impact on dialysis quality by reduced time on dialysis.
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
- •Written consent of the participant after being informed
- •At least 18 years of age
- •End stage kidney disease patient undergoing hemodialysis
- •Dry weight stable for a minimum of one month
- •Interdialytic weight gain of >2 liters in the short interdialytic interval
排除标准
- •No informed consent was obtained
- •Patients with a pacemaker or implanted medical device that prevents compliance with study regulations
- •Patients treated with hemodiafiltration
- •Patients treated with medium cut-off membranes (Theranova, Baxter)
- •Patients with recurrent severe hyperkalemia after the short interdialytic interval (K+ concentration > 6.0 mmol/L, requiring more than 2 hours of dialysis to ameliorate the post-dialytic shift from other compartments.
- •Women of childbearing age not using contraception
结局指标
主要结局
Total peripheral resistance index (TPRI)
时间窗: up to 8 weeks
Absolute change of TPRI (expressed as dyn\*sec/cm\*m2) in each individual session from baseline to the nadir.
次要结局
未报告次要终点