A Randomized Controlled Trial of Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Absolute change in IRLSSG Score
研究概览
简要总结
A randomized, double-blind controlled Study from a single center to evaluate the effect and safety of pramipexole on peritoneal dialysis patients with restless legs syndrome
详细描述
Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into experiment group and control group, and will be prescribed with pramipexole and placebo respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating Depression Scale before and after the prescription.
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
- Triple (Participant, Care Provider, Investigator)
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
- •PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate, using a twinbag connection system (Baxter Healthcare, Guangzhou, China).
- •For entry , all patients are required to meet all diagnositic criteria of the International RLS Study Group (IRLSSG), to have a baseline total score >15 on the Study Group's International RLS Rating Scale (IRLS), and to have experienced RLS symptoms at least 2-3 days per week throughout the perior 3 months.
- •Each patient should write informed consent.
- •All patients are required to be interviewed to the frequency required by the research process.
排除标准
- •Patients with severe gastrointestinal illness can not tolerate oral drugs.
- •Patients who work on a shift schedule are not allowed to participate.
- •Women with childbearing potential are excluded for pregnancy, inadequate contraception, or current breastfeeding of a child.
- •Patients are also excluded for current use (within 14 days before baseline) of medications that might affect RLS symptoms, e.g., levodopa, dopamine agonists or antagonists, hypnotics, lithium formulations, or antidepressants.
- •Patients with serum ferritin ≤200 ng/ml, or Hb <110g/L, or Kt/V <1.7 are excluded.
- •Patients with severe and unstable inflammation disease (active systemic infection, acute cardiovascular disease, active liver disease, active connective tissue disorder, ,and cancer within 1 year of radiotherapy and chemotherapy, )
研究组 & 干预措施
Treatment group
Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.
干预措施: Pramipexole (Drug)
Treatment group
Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.
干预措施: placebo (Other)
Control group
Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.
干预措施: placebo (Other)
结局指标
主要结局
Absolute change in IRLSSG Score
时间窗: 12 weeks
Absolute change in IRLS sum score will be defined as a change in IRLSSG from baseline to the end of treatment phase. The scale range from 0 to 40. The higher values represent a worse outcome.
次要结局
- Effect on Sleep assessment Questionnaire(12 weeks)
- Effect on Quality of life (QoL) questionare(12 weeks)
- Effect on self rating anxiety scale(12 weeks)
- Effect on depression self rating scale(12 weeks)
- Effects on Blood pressure(12 weeks)
研究者
Dong Jie
Clinical Professor
Peking University First Hospital