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Completed

NCT Number: NCT06723223

Novel Combined Function Test for 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Reliability of the combined peritoneal equilibrium test

    Time frame: 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 outcomes

  1. Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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