The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the longitudinal changes of itching
研究概览
简要总结
A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.
There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
详细描述
All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to sign an informed consent
- •Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- •middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) > 400 pg/mL, β2MG>5000 pg/ml、CRP>10mg/l.
- •Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.
排除标准
- •Incapable or reluctant to sign the informed consent or comply the schedule.
- •platelet (PLT) count<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
- •Severe hypotension and heart or lung insufficiency
- •Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
- •Attend to other clinic trial now or in recent 30 days
结局指标
主要结局
the longitudinal changes of itching
时间窗: every week, up to 12 weeks.
次要结局
- the longitudinal changes of serum middle molecules of β2MG concentrations(every week,up to 12 weeks.)
- the longitudinal changes of serum middle molecules of ADMA concentrations(every week,up to 12 weeks.)
- the longitudinal changes of the nutritional status(every week,up to 12 weeks.)
- the longitudinal changes of serum middle molecules of iPTH concentrations(every week,up to 12 weeks.)
- the longitudinal changes of serum middle molecules of CRP concentrations(every week,up to 12 weeks.)
- the longitudinal changes of serum middle molecules of BMP2concentrations(every week,up to 12 weeks.)
研究者
Xue Qing Yu
Director
Sun Yat-sen University