Comparison of Efficacy Between Nighttime vs Daytime Peritoneal Dialysis in Non-diabetic Patients: a Randomized, Open-label, Cross-over, Multi-center Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Fanfan Hou, MD,PhD
ffhouguangzhou@163.com
+86-020-61641591
Backup
Jun Ai, MD
aij1980@163.com
+86-020-62787120
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 124
Treatments
Experimental: Nocturnal Continuous Cyclical Peritoneal Dialysis (NCPD)
In NCPD, patients uses a machine to exchange fluid to perform dialysis at night.
Active_comparator: Continuous Ambulatory Peritoneal Dialysis (CAPD)
In CAPD, patients perform dialysis with manual fluid change at daytime .
Related Therapeutic Areas
Sponsors
Collaborators: Fujian Provincial Hospital, The Affiliated Ganzhou Hospital of Nanchang University, Fuzhou First General Hospital Affiliated with Fujian Medical University, The First Affiliated Hospital of Guangzhou Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Dongguan Tungwah Hospital, Guizhou Provincial People's Hospital, The First People's Hospital of Nanning, Guangzhou First People's Hospital, First People's Hospital of Yulin, Tianjin Medical University Second Hospital
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov

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