Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients (CSEPR)

The investigators will carry out a prospective cross-over, pre-and post-controlled clinical study : 36 patients with continuous ambulatory peritoneal dialysis with high/high average transport will be recruited and treated with continuous ambulatory peritoneal dialysis and intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month respectively. The changes of peritoneal transport function and ultrafiltration volume before and after the two dialysis methods will be compared.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease 5D
• Intervention / Treatment: Combination product: peritoneal rest

Detailed Description

1. Inclusion Criteria

   • Continuous ambulatory peritoneal dialysis for more than 3 months;
   • The peritoneal transport function is high/high average transport (D/Pcr>0.65 at 4 hours in the peritoneal balance test);
   • Sign the informed consent form voluntarily.

2. Exclusion Criteria

   • Patients with peritonitis in the past 3 months;
   • Patients with acute complications such as cardiovascular events, pulmonary infection and gastrointestinal bleeding in the past 3 months;
   • The doctor judged that it was not suitable for the patients in this study for other reasons.

3. Treatment plan

   The patients will be divided into two groups randomly: group A carry on continuous ambulatory peritoneal dialysis (the original dialysis plan) for 1 month, and then changed to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine，the concentration and dosage of dialysate are consistent with the original plan) for 1 month; Group B carry on intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine，the concentration and dosage of dialysate are consistent with the original plan) for 1 month, and then change to continuous ambulatory peritoneal dialysis (original dialysis plan) for 1 month.

4. Observation indicators

Main observation indicators:

Changes in peritoneal transport rate (represented by 4-hour D/Pcr in the standard peritoneal balance test) and ultrafiltration volume (represented by 4-hour ultrafiltration volume in the standard peritoneal balance test) before and after daytime dry abdomen (intermittent peritoneal rest) and continuous peritoneal dialysis.

Secondary outcome measures:

changes in IL-1, IL-6 and TNF- α， VEGF and CTGF of the exudate in the standard peritoneal balance test before and after daytime dry abdomen (intermittent peritoneal rest) and continuous peritoneal dialysis .

Changes of body weight, blood pressure, hemoglobin, albumin, calcium, phosphorus, electrolyte, urea clearance index, etc. before and after daytime dry abdomen (intermittent peritoneal rest) and continuous peritoneal dialysis.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria：

• Continuous ambulatory peritoneal dialysis for more than 3 months;
• The peritoneal transport function is high/high average transport (D/Pcr>0.65 at 4 hours in the peritoneal balance test);
• Sign the informed consent form voluntarily.

Exclusion criteria：

• Patients with peritonitis in the past 3 months;
• Patients with acute complications such as cardiovascular events, pulmonary infection and gastrointestinal bleeding in the past 3 months;
• The doctor judged that it was not suitable for the patients in this study for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; group A carry on continuous ambulatory peritoneal dialysis (the original dialysis method) for 1 month, and then changed to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month	Combination product: peritoneal rest; Change continuous ambulatory peritoneal dialysis to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month. In this way, give a chance of peritoneum rest.
Experimental: Group B; Group B carry on intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month, and then change to continuous ambulatory peritoneal dialysis (original dialysis method) for 1 month.	Combination product: peritoneal rest; Change continuous ambulatory peritoneal dialysis to intermittent peritoneal dialysis at night (using automatic peritoneal dialysis machine) for 1 month. In this way, give a chance of peritoneum rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peritoneal transport rate	represented by 4-hour D/Pcr in the standard peritoneal balance test	1 month
ultrafiltration volume	represented by 4-hour ultrafiltration volume in the standard peritoneal balance test	1 month

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Li Zuo, Doctor, Peking University People's Hospital

Publications and helpful links

General Publications

• Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.
• Maksic D, Vasilijic S, Colic M, Stankovic-Popovic V, Bokonjic D. Systemic and intraperitoneal proinflammatory cytokine profiles in patients on continuous ambulatory peritoneal dialysis. Adv Perit Dial. 2009;25:50-5.
• Toda N, Mori K, Kasahara M, Koga K, Ishii A, Mori KP, Osaki K, Mukoyama M, Yanagita M, Yokoi H. Deletion of connective tissue growth factor ameliorates peritoneal fibrosis by inhibiting angiogenesis and inflammation. Nephrol Dial Transplant. 2018 Jun 1;33(6):943-953. doi: 10.1093/ndt/gfx317.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: peritoneal rest trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No