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

Chronic Kidney Disease 5D Clinical Trial

— CSEPR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805813
• Other study ID #: peritoneal rest trial
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Peking University People's Hospital
• Contact: Bei Wu, Doctor
• Phone: +8601088325429
• Email: wubei218[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 — View Citation

Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peritoneal transport rate	represented by 4-hour D/Pcr in the standard peritoneal balance test	1 month
Primary	ultrafiltration volume	represented by 4-hour ultrafiltration volume in the standard peritoneal balance test	1 month