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Enrolling by invitation NCT06841224

The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease

Observational Peritoneal Dialysis Polycystic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Peritoneal Dialysis, Polycystic Kidney Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Increased IPP points to higher risk of abdominal wall complications and limited infusion volume that cause insufficient dialysis adequacy. Therefore, monitoring IPP is especially important in patients with polycystic kidney disease. However, the standard measurement of IPP is limited due to its cumbersome procedures, the application value of equation for estimating IPP among general peritoneal dialysis patients is not clear in the PKD population and the variables influence the IPP is yet to be explored.. Objective: The main purpose of our study was to validate the existing IPP equations in the PKD patients. Further, more relevant variables were included to optimize the IPP equation. Monitoring IPP can guide the formulation of peritoneal dialysis prescription for ADPKD patients, reduce the occurrence of abdominal wall complications, and the clinical utility and efficiency of PD was expanded. Methods: A multi-center cross-sectional study. The IPPs were measured using the Durand method, with whole-body and abdominal anthropometry indices, the volume of abdominal cavity, the total kidney volume and liver volume were collected. New equation for estimate IPP in PKD patients were generated by stepwise linear regression modeling. The eIPP were calculated using two developed equations previously. Then The bias, accuracy and precision of eIPP derived from new equation were compared with actual IPP by Durand method respectively.

Primary outcome measures

  • intraperitoneal pressure [Time frame: 20 minutes]

Eligibility criteria

Inclusion criteria

  • Aged 18-80 years;
  • A confirmed diagnosis of polycystic kidney disease, with a history of peritoneal dialysis catheter placement and regular peritoneal dialysis;
  • Able to tolerate the infusion of more than 1500 mL of dialysis fluid.

Exclusion criteria

  • Acute complications such as peritonitis or cardiovascular and cerebrovascular events within the past month;
  • History of abdominal surgery or trauma within the past month;
  • History of kidney cyst rupture, infection, or bleeding within the past month;
  • History of abdominal or pelvic organ tumors;
  • History of abdominal pressure-related complications, such as hernias, leaks, or chest-abdominal fistulas;
  • Unable to attend follow-up visits during the study period;
  • Refusal to participate in the study. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking university First hospital — Beijing

Identifiers

NCT: NCT06841224 · IPP in ADPKD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗