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

Primary Purpose

Chronic Kidney Disease 5D

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
peritoneal rest
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease 5D

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

group 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 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.

Outcomes

Primary Outcome Measures

peritoneal transport rate
represented by 4-hour D/Pcr in the standard peritoneal balance test
ultrafiltration volume
represented by 4-hour ultrafiltration volume in the standard peritoneal balance test

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
June 18, 2023
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05805813
Brief Title
Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients
Acronym
CSEPR
Official Title
Cross-control Study on the Effect of Peritoneal Rest on Peritoneal Transport Function in Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease 5D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
group 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
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group 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.
Intervention Type
Combination Product
Intervention Name(s)
peritoneal rest
Intervention Description
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.
Primary Outcome Measure Information:
Title
peritoneal transport rate
Description
represented by 4-hour D/Pcr in the standard peritoneal balance test
Time Frame
1 month
Title
ultrafiltration volume
Description
represented by 4-hour ultrafiltration volume in the standard peritoneal balance test
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bei Wu, Doctor
Phone
+8601088325429
Email
wubei218@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huiping Zhao, Doctor
Phone
+8601088325561
Email
huipingzhao2009@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zuo, Doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bei Wu, Doctor
Phone
+8601088325429
Email
wubei218@163.com
First Name & Middle Initial & Last Name & Degree
Huiping Zhao, Doctor
Phone
+8601088325561
Email
huipingzhao2009@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2663040
Citation
Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.
Results Reference
result
PubMed Identifier
19886317
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.
Results Reference
result
PubMed Identifier
29165602
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.
Results Reference
result

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

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