Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Glucose absorption
研究概览
简要总结
This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.
详细描述
Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. However, in light of the growing number of diabetic patients on PD, the unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B, 2017, see references), using a theoretical model of APD, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having "UF cycles" using a higher glucose concentration (e.g. 2.27% glucose) and "Clearance cycles" using a low glucose concentration (e.g. 0.1% glucose).
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
- •age between 18 and 75 years;
- •duration of PD (automated peritoneal dialysis (APD) or continuous ambulatory peritoneal dialysis (CAPD)) >4 weeks
排除标准
- •severe heart failure (New York Heart Association Functional Classification; NYHA III or IV);
- •pregnancy;
- •catheter malfunction or
- •peritonitis within 3 months prior to the trial.
研究组 & 干预措施
Standard treatment
APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.
干预措施: Automated peritoneal dialysis (APD) (Procedure)
Optimized treatment
APD-treatment with a net volume of 14 L 2.27 % anhydrous glucose peritoneal dialysis solution during 280 minutes followed by a net volume of 10 L 0.1 % glucose dialysis fluid during 200 minutes.
干预措施: Automated peritoneal dialysis (APD) (Procedure)
结局指标
主要结局
Glucose absorption
时间窗: Through study completion, up to 1 year
Amount of glucose absorbed across the peritoneal membrane during the treatment
次要结局
- Ultrafiltration(Through study completion, up to 1 year)
- Urea clearance(Through study completion, up to 1 year)
- Creatinine clearance(Through study completion, up to 1 year)
- Sodium removal(Through study completion, up to 1 year)
- Incidence of complications(Up to 14 days post-intervention)