Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02863016
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2016-08-01
Brief Title:
Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers
Sponsor:
Ospedale Santa Maria Annunziata
Organization:
Ospedale Santa Maria Annunziata
Study Overview
Official Title:
tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS HEPHAESTUS Study
Status:
COMPLETED
Status Verified Date:
2020-12
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:
HEPHAESTUS
Brief Summary:
The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate Cit- 1 mM Citrate in online postidultion HDF with high volumes compared to traditional concentrated Ac- 3 mM of acetate in the medium term In addition the study will evaluate other parameters of efficiency dialysis cardiovascular stability the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term
Detailed Description:
The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate Cit-HDF in 3 months can reduce the inflammation markers evaluated by a Predialytic value of Beta2-microglobulin B2m CRP and IL6 compared to traditional concentrated acetic acid Ac-HDF
The secondary objectives of this study are to evaluate if Cit-HDF compared to Ac-HDF can have an effect in a period of 3 months on the following aspects
the change weekly pre-dialysis values of other markers of oxidative stress TAC NF-kB
the technical parameters of HDF treatment such as convective volumes and blood pressure in the circuit in the filter TMP pressure pre-filter
the cardiovascular stability through blood pressure and heart rate before and after dialysis SBP DBP HR and number of intradialytic hypotension
the parameters of safety as the variation of the values of the mobility Predialytic bone PTH alkaline phosphatase fetuin-A the variation of the values intradialytic biochemical impacted by citrate total and ionized calcium bicarbonate and clotting time aPTT
the variation of calcifications observed by
the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler optional
dialysis efficiency by varying pre-and post-dialysis RR and Clearance average molecular weight solutes with small and medium Phosphorus Beta2 Micro Myoglobin and indices of dialysis adequacy of small molecules such as EKT V based on the dialysance ion formula Watson calculated automatically by the monitor to dialysis
The secondary objectives of this study are to evaluate if Cit-HDF compared to Ac-HDF can have an effect in a period of 3 months on the following aspects
the change weekly pre-dialysis values of other markers of oxidative stress TAC NF-kB
the technical parameters of HDF treatment such as convective volumes and blood pressure in the circuit in the filter TMP pressure pre-filter
the cardiovascular stability through blood pressure and heart rate before and after dialysis SBP DBP HR and number of intradialytic hypotension
the parameters of safety as the variation of the values of the mobility Predialytic bone PTH alkaline phosphatase fetuin-A the variation of the values intradialytic biochemical impacted by citrate total and ionized calcium bicarbonate and clotting time aPTT
the variation of calcifications observed by
the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler optional
dialysis efficiency by varying pre-and post-dialysis RR and Clearance average molecular weight solutes with small and medium Phosphorus Beta2 Micro Myoglobin and indices of dialysis adequacy of small molecules such as EKT V based on the dialysance ion formula Watson calculated automatically by the monitor to dialysis
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