Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- 5D Elman Itch Scale total score
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.
The main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?
Researchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.
Participants will:
- receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months;
- fill in questionnaires about intensity of pruritis and its impact on daily life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
- •Moderate-to-severe pruritis (WI-NRS score ≥ 4);
- •Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
- •Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
- •Signed informed consent.
排除标准
- •Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
- •Noncompliance of the patient with the protocol (in the investigator's opinion).
- •Use of haemodiafiltration.
结局指标
主要结局
5D Elman Itch Scale total score
时间窗: From enrollment to the end of treatment at 8 weeks
The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.
次要结局
- WI-NRS score(From the end of active treatment to the end of follow-up (4 weeks))
- Skindex-16 score(From the end of active treatment to the end of follow-up (4 weeks))
- Itch-MOS score(From the end of active treatment to the end of follow-up (4 weeks))
- 5D Elman Itch Scale total score(From the end of active treatment to the end of follow-up (4 weeks))
- C-reactive protein concentration(From enrollment to the end of treatment at 8 weeks)
- Serum ferritin(From enrollment to the end of treatment at 8 weeks)
研究者
Ekaterina Parshina
Chief of Nephrology and Dialysis department
Saint Petersburg State University, Russia