Background: Compared with continuous ambulatory peritoneal dialysis (CAPD), nocturnal continuous cyclic peritoneal dialysis (NCPD) uses a machine to exchange fluid to perform dialysis at night, allowing patients to work or study normally during daytime. Since the dialysis fluid retention time of NCPD patients is shorter than that of CAPD, this RCT was designed to investigate whether there is a difference in the efficacy between the two modalities on peritoneal dialysis. Design: Randomized, open-label, cross-over, multi-center clinical trial. Objective: Primary Objective: To compare the adequacy of peritoneal dialysis between NCPD and CAPD in non-diabetic patients. Secondary Objective: To compare the effects of NCPD and CAPD on the quality of life, including sleep quality, nocturnal blood pressure, and ultra-filtration volume in non-diabetic patients. Hypothesis: In non-diabetic patients, NCDP is non-inferior to CAPD in peritoneal dialysis adequacy. Methods: A total of 124 non-diabetic peritoneal dialysis patients will be enrolled and randomly assgined into two groups in a 1:1 ratio. Patients in group A will receive NCPD treatment from 1 to 12 weeks and then switch to CAPD treatment from 13 to 24 weeks, while patients in group B will receive CAPD treatment from 1 to 12 weeks and then switch to NCPD treatment from 13 to 24 weeks. All patients are required to sign an informed consent before enrollment. The enrolled patients are planned to be followed every 4 weeks, and unplanned visits will be arranged if necessary. The peritoneal dialysis adequacy (weekly total Kt/V) of the patients will be assessed at baseline and at the corresponding visit points. The average daily ultra-filtration volume during the two modalities of treatment will be compared. Sleep quality parameters will be collected using a contact-free continuous vital signs monitoring equipment at baseline, Week 12 and Week 24. The health-related quality of life and social function will be analyzed using the Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) and Social Disability Screening Schedule (SDSS) questionnaire. Twenty-four-hour Ambulatory Blood Pressure (ABP) will be monitored at baseline, Week 12, and Week 24.
Sample Size Estimation: Clinical data from previous studies showed that the total weekly Kt/V of non-diabetic peritoneal dialysis patients was 2.4 (95% CI: 1.46-3.38), the change in Kt/V after 3 months of treatment was -0.02 (95% CI: -0.64-0.59), and the standard deviation of the change was 0.31 (95% CI: 0.26-0.36). Based on the above data, we estimated the sample size. For the primary efficacy outcome (the difference of Kt/V score between NCPD and CAPD patients), the non-inferiority test shows that 110 patients could provide 90% power to detect an absolute difference of 0 when the margin of non-inferiority is 0.1 with a common standard deviation of 0.36 at one-sided significance level α=0.025. Considering the 10% rate of loss to follow-up, 124 cases (62 cases in each sequence) will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGTotal Weekly Kt/V
Total weekly Kt/V will be detected at baseline and every visit point (Week 0, 4, 8, 12, 16, 20, and 24). The mean total weekly Kt/V score during NCPD treatment will be compared with that of CAPD. Standardized formula will be used to calculate total weekly Kt/V score: Kt/V = Kd×T/V. Kd is peritoneal urea nitrogen removal rate. T is the time (unit: min). V represents the urea distribution volume (weight×0.58).
Time frame: Week 0, 4, 8, 12, 16, 20, and 24
Sleep Quality
Sleep quality will be monitored by a contact-free continuous vital signs monitoring equipment at Week 12 and Week 24. Total sleep duration, time required to fall asleep, duration and proportion of deep/light sleep/REM phases, awake duration, and number of body movements will be reported after sleep monitoring.
Time frame: Week 12, and 24
Health-related Quality of Life and Social Function
Kidney Disease Quality of Life Short Form 36 (KDQOL-36), a self-reported questionnaire, will be assessed at baseline, Week 12, and Week 24. The total scores will be calculated to evaluate the health-related quality of life at every module after transformed raw scores linearly to a range of 0 (minimum value) to 100 (maximum value) . Social Disability Screening Schedule (SDSS) questionnaire will be assessed at baseline, Week 12, and Week 24. The total score will be calculated to evaluate the social function.
Time frame: Week 0, 12, and 24
Ambulatory Blood Pressure (ABP)
Twenty-four-hour ABP will be monitored at baseline, Week 12, and Week 24, including daytime average blood pressure, nocturnal average blood pressure, and blood pressure variability.
Time frame: Week 0, 12, and 24
Peritoneal Ultrafiltration Volume (UV)
Peritoneal UV will be recorded daily during treatment. The average peritoneal UV will be compared between the two modalities. Net ultrafiltration volume will be calculated as the volume of the drained dialysate (L) minus the volume of infused dialysis fluid (L).
Time frame: Everyday during treatment
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