The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- ultrafiltration measured in ml
研究概览
简要总结
Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients.
However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use.
Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.
详细描述
- Patients who met the inclusion criteria will be enrolled in this study.
- Randomization.
- Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization.
- Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort.
- Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.
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
- •End-stage renal failure
- •Patients with regular peritoneal dialysis in our center
- •18-75 years old
- •Patients who currently use glucose dialysate for prolonged abdominals
- •Sign informed consent
排除标准
- •The expected survival time is less than 3 months
- •Known peritoneal dialysis tube dysfunction
- •Peritonitis occurred within one month
- •Known peritoneal effusion
- •Known allergy to icodextrin
研究组 & 干预措施
daily
daily use of one exchange of icodextin as long dwell
干预措施: Icodextrin Peritoneal Dialysis Solution (Drug)
alternative day
alternative day use of one exchange of icodextin as long dwell
干预措施: Icodextrin Peritoneal Dialysis Solution (Drug)
结局指标
主要结局
ultrafiltration measured in ml
时间窗: 2 weeks
ultrafiltration volume for single icodextrin dwell
次要结局
- daily treatment cost measured in Chinese Yuan(2 weeks)
研究者
Zanzhe Yu
Principal investigator
RenJi Hospital