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

Not Applicable
Completed
Conditions
Chronic Kidney Disease 5D
Interventions
Combination Product: peritoneal rest
Registration Number
NCT05805813
Lead Sponsor
Peking University People's Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Group Aperitoneal restgroup 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
Group Bperitoneal restGroup 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.
Primary Outcome Measures
NameTimeMethod
ultrafiltration volume1 month

represented by 4-hour ultrafiltration volume in the standard peritoneal balance test

peritoneal transport rate1 month

represented by 4-hour D/Pcr in the standard peritoneal balance test

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Peking University People's Hospital

🇨🇳

Beijing, Beijing, China

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