Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443021
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-17
Brief Title:
Influence of Variable Inflow Volume Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Fresenius Medical Care Deutschland GmbH
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pPD
Brief 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 eg total peritoneal clearance
Analysis of daily dietetic fluid intake weight and further parameters documented by the patient in a patient diary
- 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 eg total peritoneal clearance
Analysis of daily dietetic fluid intake weight and further parameters documented by the patient in a patient diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None