Novel Combined Function Test for Patients on Peritoneal Dialysis

Clinical Validation of a Combined Equilibration Test in Patients on Peritoneal Dialysis

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.

Study Overview

• Status: Completed
• Conditions: End Stage Kidney Disease (ESRD)
• Intervention / Treatment: Diagnostic test: Traditional Peritoneal Equilibrium Test; Diagnostic test: Combined Peritoneal Equilibrium Test

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Hemdialysmottagningen, Skånes Universitetssjukhus (SUS) Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eligible patients

Diagnostic test: Traditional Peritoneal Equilibrium Test; The first day started with a traditional PET consisting of a 240-minutes dwell with 2.3% glucose PD solutions. The intervention includes sampling of blood plasma (Na, K, glucose, creatinine, urea and albumin) and dialysate (Na, K, glucose, creatinine, urea and albumin).; Diagnostic test: Combined Peritoneal Equilibrium Test; The PET test on the first day (Day 1) was followed by a short (60 min) combined PET with 4.25% glucose solution. On the second day (Day 2), the combined PET was repeated. The intervention includes sampling of blood plasma (Na, K, glucose, creatinine, urea and albumin) and dialysate (Na, K, glucose, creatinine, urea and albumin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the combined peritoneal equilibrium test	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)	All interventions need to be completed within one month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test	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.	All interventions are performed within one month.

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Carl M Öberg, M.D., Ph.D., Lund University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Peritoneal dialysis; Peritoneal equilibration test; CombiPET
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: CPET202002377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No