NCT06841224

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

February 24, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

February 18, 2025

Last Update Submit

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

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.

Locations