Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Serum p-cresyl sulfate (PCS)
研究概览
简要总结
This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD/HDF alone; HD/HDF plus biweekly pHA130 hemoperfusion; or HD/HDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, with no restriction on gender;
- •Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
- •Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
排除标准
- •Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
- •Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
- •Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
- •Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
- •Patients with a platelet count < 60 × 10⁹/L;
- •Other conditions deemed unsuitable for enrollment in this study by the researchers.
研究组 & 干预措施
experimental group
Treatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.
干预措施: pHA130 hemoperfusion device (Device)
experimental group
Treatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.
干预措施: HD/HDF (Device)
control group 1
Control Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours.
干预措施: HD/HDF (Device)
control group 2
Control Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.
干预措施: HD/HDF (Device)
control group 2
Control Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.
干预措施: HA130 hemoperfusion device (Device)
结局指标
主要结局
Serum p-cresyl sulfate (PCS)
时间窗: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
Serum indoxyl sulfate (IS)
时间窗: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
次要结局
- Parathyroid hormone (PTH)(before/after a single treatment session)
- β2-microglobulin (β2-MG)(before/after a single treatment session)
- Serum indoxyl sulfate (IS)(before/after a single treatment session)
- Serum p-cresyl sulfate (PCS)(before/after a single treatment session)
- Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score(Week 0 to Week 24 (±7 days))
- Pruritus severity score(Week 0 to Week 24 (±7 days))
- Pittsburgh Sleep Quality Index (PSQI)(Week 0 to Week 24 (±7 days))
- Hospitalization rate(Week 0 to Week 24 (±7 days))
- Mortality rate(Week 0 to Week 24 (±7 days))