Novel Combined Function Test for Patients on Peritoneal Dialysis

Not Applicable

Completed

• Conditions: End Stage Kidney Disease (ESRD)

• Registration Number: NCT06723223
• Lead Sponsor: Lund University

Brief Summary

Peritoneal membrane function tests such as the traditional peritoneal equilibrium test (PET) aid in the assessment of various peritoneal membrane functions, and are widely used in clinical practice to guide dialysis prescription, and also to monitor the integrity of the peritoneal membrane over time. Traditional tests do however have several shortcomings such as being time consuming, complex, and having a low reliability. Also, present functional tests often provide limited information such as small solute transfer rates, which means that other functional changes go unnoticed.

The present study investigates the reliability of a novel short (60 min) test, with the potential of replacing complex and time-consuming conventional tests. The novel test provides a comprehensive assessment on both water- and solute transfer across the peritoneal membrane, including the osmotic conductance to glucose (OCG), small solute diffusive conductance (in terms of the diffusive surface to diffusion length ratio, A0/Δx), and also macromolecular transport and apparent fluid absorption. In contrast to conventional tests, multiple fill volumes may be used and results are also applicable to all glucose strengths used in conventional peritoneal dialysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-02
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Peritoneal dialysis treatment duration of at least 1 month
• No recent peritonitis (a minimum of 1 month since the last peritonitis)

Exclusion Criteria

• Pregnancy
• Participant unable to provide informed consent
• Peritonitis
• Other acute infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reliability of the combined peritoneal equilibrium test	All interventions need to be completed within one month.	Reliability of the novel test will be assessed using the Intraclass Correlation Coefficient (ICC) evaluating consistency and repeatability of key continuous measurements (osmotic conductance to glucose, diffusive conductance, albumin clearance, and apparent fluid absorption) across the two different test occasions (Day 1 and Day 2)

Secondary Outcome Measures

Name	Time	Method
Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test	All interventions are performed within one month.	The key continuous outcome measures (osmotic conductance to glucose and diffusive conductance) from the combined peritoneal equilibrium test (PET) will be inserted into the isocratic model (and the three-pore model) for peritoneal dialysis to test if the results in the traditional PET can be accurately reproduced. The rationale is to elucidate if the combined PET contains the same information as the tradional PET or if information is lost in the much shorter combined PET.

Trial Locations

Locations (1)

Hemdialysmottagningen, Skånes Universitetssjukhus (SUS) Lund; 🇸🇪 Lund, Sweden