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Novel Combined Function Test for Patients on Peritoneal Dialysis

NCT ID: NCT06723223

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-10-26

Brief Summary

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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

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Conditions

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End Stage Kidney Disease (ESRD)

Keywords

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Peritoneal dialysis Peritoneal equilibration test CombiPET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Eligible patients

Group Type EXPERIMENTAL

Traditional Peritoneal Equilibrium Test

Intervention Type 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

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl M Öberg, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Hemdialysmottagningen, Skånes Universitetssjukhus (SUS) Lund

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CPET202002377

Identifier Type: -

Identifier Source: org_study_id