Novel Combined Function Test for Patients on Peritoneal Dialysis

NCT06723223 | Completed

• 1 other identifier: CPET202002377
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Kidney Disease (ESRD)

Keywords

Peritoneal dialysis; Peritoneal equilibration test; CombiPET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test

  All interventions are performed within one month.

Study Arms (1)

Eligible patients

EXPERIMENTAL

Diagnostic Test: Traditional Peritoneal Equilibrium Test; Diagnostic Test: Combined Peritoneal Equilibrium Test

Interventions

Traditional Peritoneal Equilibrium Test DIAGNOSTIC_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).

Eligible patients

Combined Peritoneal Equilibrium Test DIAGNOSTIC_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).

Eligible patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Hemdialysmottagningen, Skånes Universitetssjukhus (SUS) Lund

Lund, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl M Öberg, M.D., Ph.D.

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 2, 2021
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

SE (1)