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Completed

NCT Number: NCT05805813

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

peritoneal rest

Combination Product

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 outcomes

  1. peritoneal transport rate

    Time frame: 1 month

    represented by 4-hour D/Pcr in the standard peritoneal balance test

  2. ultrafiltration volume

    Time frame: 1 month

    represented by 4-hour ultrafiltration volume in the standard peritoneal balance test

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Acronym: CSEPR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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