Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02748733
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-04-13
Brief Title:
Proof of Concept of Adapted PD in Children PC-AAPD
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Randomized Cross-over Comparison of Double Mini PET With Standard vs Adapted Dwell Volume and Dwell Time - Proof of Concept of Adapted PD
Status:
COMPLETED
Status Verified Date:
2018-05
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:
PC-AAPD
Brief Summary:
The purpose of this study is to validate the concept of adapted automated PD a modified Peritoneal Equilibration Test PET will be performed in children on chronic PD Instead of a single 4 hour standard dwell two double mini PET using the same type and total volume of dialysate and the same total dwell time 150min will be performed in randomised sequence An double mini test consists of two identical dwells reflecting routine PD the other one of a short small dwell followed by a long large dwell as suggested from adapted PD regimes successfully applied in adult PD patients
Detailed Description:
Present peritoneal dialysis treatment is hampered by the limited efficacy of currently applied regimen mainly consisting of a series of standard dwells with the same amount of dialysate and dwell time New cycler machines available for routine therapy now allow modification of time and volume of each dwell and thus to individually adapt PD regime In fact a recent multi-center trial in adult patients suggests that a PD regimen consisting of a sequence of short small dwells followed by large and long lasting dwells in total applying the same amount of dialysate during the same total treatment time substantially improves fluid and toxin removal Underlying beneficial mechanisms are highly debated Prior to adaptation of such PD treatment patterns to children on automated PD in the routine clinical setting the tolerability and biochemical effects need to be demonstrated
To this end the Peritoneal Equilibration Test PET which is routinely performed in children during a day hospital treatment to analyse peritoneal transport function will be modified Instead of a single 4 hour standard dwell two double mini PET using the same type and total volume of dialysate and the same total dwell time 150min will be performed in randomised sequence in a total of 15 stable pediatric PD patients treated in four different European pediatric dialysis centres The conventional double mini PET consists of two identical cycles fill volume 1 Lm² 75 min the adapted one of a short small cycle 06 mLm² BSA 30 min followed by a long large cycle 14 mLm² 120 min A total of 22 ml of blood will be drawn via a peripheral iv line intraperitoneal pressure in clinical routine controlled once during a PET will be measured with each dwell
The study analyses the time and volume dependent PD transport mechanisms Patients included may benefit from the detailed analysis of peritoneal membrane function allowing for optimisation of the individual PD prescription
To this end the Peritoneal Equilibration Test PET which is routinely performed in children during a day hospital treatment to analyse peritoneal transport function will be modified Instead of a single 4 hour standard dwell two double mini PET using the same type and total volume of dialysate and the same total dwell time 150min will be performed in randomised sequence in a total of 15 stable pediatric PD patients treated in four different European pediatric dialysis centres The conventional double mini PET consists of two identical cycles fill volume 1 Lm² 75 min the adapted one of a short small cycle 06 mLm² BSA 30 min followed by a long large cycle 14 mLm² 120 min A total of 22 ml of blood will be drawn via a peripheral iv line intraperitoneal pressure in clinical routine controlled once during a PET will be measured with each dwell
The study analyses the time and volume dependent PD transport mechanisms Patients included may benefit from the detailed analysis of peritoneal membrane function allowing for optimisation of the individual PD prescription
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None