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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. 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.

Official Title
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Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients

Conditions
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Chronic Kidney Disease 5D

Intervention / Treatment
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* Combination Product: peritoneal rest


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* 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.<br>|
| Experimental: Group B<br>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<br>* 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.<br>|

What is the study measuring?
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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 |