Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Reduction Rate of Serum Indoxyl Sulfate (IS)
研究概览
简要总结
This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.
详细描述
Patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) have a high burden of uremic toxins, particularly protein-bound uremic toxins (PBUTs), which are poorly cleared by conventional dialysis and are associated with high cardiovascular mortality. hemoadsorption (HA) is an adjunctive blood purification technique effective at removing PBUTs. The standard duration for HA sessions is typically 2-2.5 hours. However, emerging evidence suggests that extending the treatment duration may enhance toxin removal. This study aims to rigorously compare the efficacy and safety of a 4-hour HA session combined with hemodialysis against a standard 2-hour session in clearing key PBUTs like Indoxyl Sulfate (IS) and p-Cresyl Sulfate (PCS). The findings will provide crucial evidence for optimizing HA treatment protocols to improve toxin clearance and potentially patient outcomes in the ESRD population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years, regardless of gender
- •Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen
- •Receiving hemodialysis 3 times per week, each session lasting ≥4 hours
- •Single-pool Kt/V (spKt/V) ≥1.2 within 8 weeks prior to enrollment
- •Willing and able to sign the informed consent form
排除标准
- •Life expectancy less than 1 year
- •White blood cell count < 4 × 10⁹/L and/or platelet count < 60 × 10⁹/L
- •Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders
- •Active malignant tumor
- •Active infection
- •Pregnant or breastfeeding
- •Participation in another clinical trial within the past month or currently enrolled in one
- •Deemed unsuitable for the study by the investigator
结局指标
主要结局
Reduction Rate of Serum Indoxyl Sulfate (IS)
时间窗: At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit
The reduction rate (RR) of serum Indoxyl Sulfate (IS) after a single HAHD treatment session. The RR is calculated as: RR(%) = (1 - (Post-treatment Concentration / Pre-treatment Concentration)) × 100. Post-treatment concentration will be corrected for hemoconcentration.
次要结局
- Reduction Rate of p-Cresyl Sulfate (PCS)(At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit)
- Change from Baseline in Pre-dialysis IS levels(Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18))
- Clearance of Other Uremic Toxins(Week 1, Week 8, Week 11, Week 18)
- Change from Baseline in Pre-dialysis PCS levels(Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18))
- Number of Participants With Adverse Events, Circuit Coagulation, and Abnormal Changes in Vital Signs or Laboratory Parameters(Throughout the entire study duration (up to 18 weeks))
研究者
Li Zuo
Director
Peking University People's Hospital