Clinical trial NCT05805813: Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients
Official title: Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease 5D
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: peritoneal transport rate
timeFrame: 1 month
measure: ultrafiltration volume
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Li Zuo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.
citation: 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.
citation: 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.