The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedFebruary 24, 2025
January 1, 2025
12 months
February 18, 2025
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
intraperitoneal pressure
Actual IPP (aIPP) was measured as previously described by Durand et al.17. The peritoneal cavity was completely emptied before the test. The patient was placed briefly in a supine position on a horizontal plane and the height of the horizontal plane was standardized for all study subjects. A graduated column (cm) was bounded to the abdominal cavity through the PD catheter, with zero level placed on the midaxillary line. Two-liter dialysate solution was infused into the peritoneal cavity. We then read the height between the column of dialysate inside the PD catheter and the midaxillary line in centimetres of water (cmH2O) at non-deep expiration (IPP exp) and non-deep inspiration (IPP insp) respectively, calculating the mean of IPP exp and IPP insp. After outflowing 500 ml of the dialysate solution, we measured the aIPP again utilizing the same procedure. As a result, aIPP was measured two times for each participant. All the measurements were performed by two skillful nurses, which had
20 minutes
Eligibility Criteria
30 polycystic kidney disease patients undergoing peritoneal dialysis at 5-10 peritoneal dialysis centers nationwide from January 2024 to June 2024.
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking university First hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 24, 2025
Study Start
April 1, 2024
Primary Completion
March 30, 2025
Study Completion
March 30, 2025
Last Updated
February 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Data described in the manuscript, code book, and analytic code will not be made available because the Management of China's Human Genetic Resources.