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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05805813
Acronym
CSEPR
Enrollment
18
Registered
2023-04-10
Start date
2023-04-20
Completion date
2024-07-30
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease 5D

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.

Interventions

COMBINATION_PRODUCTperitoneal 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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
peritoneal transport rate1 monthrepresented by 4-hour D/Pcr in the standard peritoneal balance test
ultrafiltration volume1 monthrepresented by 4-hour ultrafiltration volume in the standard peritoneal balance test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026