NCT06443021

Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.

Detailed description

The primary objective of this study is: \- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes The secondary objectives of this study are: * Mean daily UFV * Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal) * Treatment parameter: performed treatment duration and volume * Fluid status measured by Body Composition Monitor (BCM) * Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time * Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR) * Extended PET * 24 h batch collection (including e.g. total peritoneal clearance) * Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary

Conditions

• Renal Failure
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DEVICE	PD cycler	After a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated. * Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician) * Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician. * Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2024-06-05
• Last updated: 2025-09-22