NCT05805813

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease 5D

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-03-31
• Completion: 2024-07-30
• First posted: 2023-04-10
• Last updated: 2024-11-07

Locations

1 site across 1 country: China