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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06443021
Study type Interventional
Source Fresenius Medical Care Deutschland GmbH
Contact Manuela Stauss-Grabo, Dr.
Phone +49 1525 469 1929
Email Manuela.Stauss-Grabo1@freseniusmedicalcare.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date January 2025

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