Nocturnal Automated Versus Continuous Ambulatory Peritoneal Dialysis in Patients With End-Stage Kidney Disease: A Multicenter, Randomized, Open-Label, Crossover Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Total Weekly Kt/V
研究概览
简要总结
Background: Continuous ambulatory peritoneal dialysis (CAPD) imposes a substantial daytime burden. Nocturnal automated peritoneal dialysis (APD) may improve patient-centered outcomes, but high-quality evidence is lacking. We aimed to determine whether nocturnal APD is non-inferior to CAPD in solute clearance and to evaluate patient-centered outcomes.
Design: A multicenter, randomized, open-label, crossover non-inferiority trial. Primary Objective: To compare the adequacy of peritoneal dialysis between nocturnal APD and CAPD in non-diabetic patients.
Secondary Objective: To compare the effects of nocturnal APD and CAPD on the quality of life, social functioning, sleep quality, blood pressure, and daily ultrafiltration volume.
Hypothesis: In non-diabetic patients, nocturnal APD is non-inferior to CAPD in peritoneal dialysis adequacy.
Methods:Eligible participants were randomly assigned in a 1:1 ratio to one of two treatment groups using a centralized block randomization system, stratified by study center. Group A consisted of 12 weeks of nocturnal APD followed by 12 weeks of CAPD; Group B consisted of the reverse order. The randomization code was generated by an independent statistical center.
The trial comprised a screening period, two 12-week treatment periods, and a follow-up period. After screening and baseline assessments, participants initiated their assigned treatment sequence. Scheduled outpatient visits occurred every 4 weeks (±5 days) for safety monitoring and routine laboratory testing. Comprehensive outcome assessments were performed at week 12 (end of the first period) and week 24 (end of the second period). Additional unscheduled visits were arranged as needed in the event of adverse events or clinical changes.
详细描述
Randomization and Masking Eligible participants were randomly assigned in a 1:1 ratio to one of two treatment groups using a centralized block randomization system, stratified by study center. Group A consisted of 12 weeks of nocturnal APD followed by 12 weeks of CAPD; Group B consisted of the reverse order. The randomization code was generated by an independent statistical center.
The trial was open-label with respect to treatment assignment, as the nature of the interventions precluded blinding of participants and treating clinicians. However, outcome adjudicators and data analysts were masked to treatment allocation throughout the analysis period. All outcome data were reviewed by an independent clinical events committee whose members were unaware of treatment assignment.
Trial Procedures The trial comprised a screening period, two 12-week treatment periods, and a follow-up period. After screening and baseline assessments, participants initiated their assigned treatment sequence. Scheduled outpatient visits occurred every 4 weeks (±5 days) for safety monitoring and routine laboratory testing. Comprehensive outcome assessments were performed at week 12 (end of the first period) and week 24 (end of the second period). Additional unscheduled visits were arranged as needed in the event of adverse events or clinical changes.
Nocturnal APD was delivered using automated cyclers (Dongze Medical, Fuzhou, China). CAPD was performed with three to five manual exchanges per day. All participants used standard peritoneal dialysis solutions (Huaren Pharmaceutical, Qingdao, China), including dextrose-based solutions (1.5%, 2.5%, and 4.25% glucose concentrations). The choice of dialysate concentration and dwell volume was determined by the treating physician according to clinical needs, with the goal of achieving adequate dialysis (weekly total Kt/V ≥ 1.7) and maintaining fluid balance. Icodextrin-based solutions were not used during the trial.
Participants recorded daily dialysate inflow and outflow volumes in patient logs, from which net ultrafiltration was calculated. Adherence to the prescribed treatment regimen was monitored through patient logs and cycler download data at each scheduled visit.
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
- Single (Outcomes Assessor)
盲法说明
The trial was open-label with respect to treatment assignment, as the nature of the interventions precluded blinding of participants and treating clinicians. However, outcome adjudicators and data analysts were masked to treatment allocation throughout the analysis period. All outcome data were reviewed by an independent clinical events committee whose members were unaware of treatment assignment.
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 18 to 75 years;
- •Maintenance peritoneal dialysis for ≥ 1 month;
- •Weekly total CrCl ≥ 45 liters/week/1.73m2 body surface area;
- •Total weekly Kt/V ≥ 1.7.
排除标准
- •Patients with diabetes mellitus;
- •Maintained peritoneal dialysis solution with a glucose concentration >2.5%;
- •Combined with acute events of cardiovascular disease(CVD), cardiac function ≥ New York Heart Association (NYHA) class III;
- •Episodes of peritonitis in the past 1 month;
- •Abdominal surgery other than PD catheter insertion in the past 3 months;
- •Planned kidney transplant in the last 6 months;
- •Active hepatitis, cirrhosis, psychiatric disease, malignancy, pregnancy.
研究组 & 干预措施
Group A
Participants receive nocturnal APD for 12 weeks and then switch to CAPD for another 12 weeks.
干预措施: Nocturnal automated peritoneal dialysis (APD) (Procedure)
Group A
Participants receive nocturnal APD for 12 weeks and then switch to CAPD for another 12 weeks.
干预措施: Continuous Ambulatory Peritoneal Dialysis (CAPD) (Procedure)
Group B
Participants receive CAPD for 12 weeks and then switch to nocturnal APD for another 12 weeks
干预措施: Nocturnal automated peritoneal dialysis (APD) (Procedure)
Group B
Participants receive CAPD for 12 weeks and then switch to nocturnal APD for another 12 weeks
干预措施: Continuous Ambulatory Peritoneal Dialysis (CAPD) (Procedure)
结局指标
主要结局
Total Weekly Kt/V
时间窗: Week 0, 4, 8, 12, 16, 20, and 24
The primary outcome was the steady-state weekly total Kt/V. For the first treatment period, it was defined as the arithmetic mean of weekly total Kt/V values measured at weeks 8 and 12; for the second treatment period, as the arithmetic mean of values measured at weeks 20 and 24. If one measurement was missing within a period, the single available value was used as the steady-state value for that period.Weekly total Kt/V was calculated as (24-hour dialysate urea clearance + 24-hour urine urea clearance) / (serum urea nitrogen concentration × urea distribution volume) × number of dialysis days per week. Urea distribution volume was estimated using the Watson formula.
次要结局
- Ultrafiltration Volume (UV)(UV is recorded daily, with analysis based on the mean of the final 7 days of each treatment period)
- Social functioning(Week 0, 12, and 24)
- Sleep Quality(Week 12, and 24)
- Health-related Quality of Life and Social Function(Week 0, 12, and 24)
- Ambulatory Blood Pressure (ABP)(Week 0, 12, and 24)
- Peritoneal Ultrafiltration Volume (UV)(Everyday during treatment)