Clinical trial NCT05449067: Comparison of Efficacy Between Nighttime and Daytime Peritoneal Dialysis
Official title: Comparison of Efficacy Between Nighttime vs Daytime Peritoneal Dialysis in Non-diabetic Patients: a Randomized, Open-label, Cross-over, Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Kidney Disease
Peritoneal Dialysis
Keywords: Nocturnal Continuous Cyclical Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysi
Dialysis Adequacy
Sleep quality
Health-related Quality of Life
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Guangzhou Medical University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Guangzhou First People's Hospital
name: Fujian Provincial Hospital
name: The Affiliated Ganzhou Hospital of Nanchang University
name: Second Affiliated Hospital of Guangzhou Medical University
name: Guangxi Yulin People's Hospital
name: Dongguan Tungwah Hospital
name: Guizhou Provincial People's Hospital
name: The First Nanning People's Hospital
name: Tianjin Medical University Second Hospital
First posted: 2022-07-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A total of 124 non-diabetic peritoneal dialysis patients will be randomly assigned to two groups in a 1:1 ratio. Patients in group A will receive NCPD from Week 1 to Week 12 and then switch to CAPD from Week 13 to Week 24. Patients in group B will receive CAPD treatment from Week 1 to Week 12 and then switch to NCPD from Week 13 to Week 24.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years;
2. Maintenance peritoneal dialysis for ≥ 1 month;
3. Weekly total CrCL ≥ 45 liters/week/1.73m2 body surface area;
4. Total weekly Kt/V ≥ 1.7.

Exclusion Criteria:

1. Patients with diabetes mellitus;
2. Maintained peritoneal dialysis solution with a glucose concentration \>2.5%;
3. Combined with acute events of cardiovascular disease(CVD), cardiac function ≥ New York Heart Association (NYHA) class III;
4. Episodes of peritonitis in the past 1 month;
5. Abdominal surgery other than PD catheter insertion in the past 3 months;
6. Planned kidney transplant in the last 6 months;
7. Active hepatitis, cirrhosis, psychiatric disease, malignancy, pregnancy.

Primary outcomes:
measure: Total Weekly Kt/V
timeFrame: Week 0, 4, 8, 12, 16, 20, and 24
Secondary outcomes:
measure: Sleep Quality
timeFrame: Week 12, and 24
measure: Health-related Quality of Life and Social Function
timeFrame: Week 0, 12, and 24
measure: Ambulatory Blood Pressure (ABP)
timeFrame: Week 0, 12, and 24
measure: Peritoneal Ultrafiltration Volume (UV)
timeFrame: Everyday during treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Fanfan Hou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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