Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00850707
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2009-02-24
Brief Title:
Vascular Access for Hemodialysis and Inflammation
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Artero-venous Fistula Prosthetic Polytetrafluoroethylene Grafts AVG Tunneled Cuffed Catheter TCC Impact of Vascular Access on HD Inflammation and Monocyte Activation
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
The aim of the present study was to investigate patients free of active infection andor thrombosis to assess if the type of vascular access AVF AVG TCC could influence
1 the levels of serological markers of inflammation CRP IL-6 TNF-a
2 the degree of expression on monocyte surface of inflammation and immune response modulating molecules CD14 CD32 and CD44
3 the amount of monocytic cells expressing a senescent phenotype CD14 and CD32
1 the levels of serological markers of inflammation CRP IL-6 TNF-a
2 the degree of expression on monocyte surface of inflammation and immune response modulating molecules CD14 CD32 and CD44
3 the amount of monocytic cells expressing a senescent phenotype CD14 and CD32
Detailed Description:
Patients with AVF assumed ticlopidine 250 mgdie patients with TCC and AVG assumed warfarin to maintain target INR between 18 and 25
Six wash out consecutive sessions were carried out before starting the study with Fresenius FX8 Helyxone for patients who underwent HD or with FX 80 Helyxone for patients who underwent hemodiafiltration HDF After the wash out period fresh whole blood and serum samples were drawn on starting dialysis during the midweek HD session for 4 consecutive weeks For each patient the mean value of the 4 blood samples was considered All patients continued HD or HDF with FX8 or FX 80 Helyxone during the whole study periodIn order to estimate the normal ranges of the parameters that we evaluated 60 anonymous healthy volunteers were also submitted to the same assays
Six wash out consecutive sessions were carried out before starting the study with Fresenius FX8 Helyxone for patients who underwent HD or with FX 80 Helyxone for patients who underwent hemodiafiltration HDF After the wash out period fresh whole blood and serum samples were drawn on starting dialysis during the midweek HD session for 4 consecutive weeks For each patient the mean value of the 4 blood samples was considered All patients continued HD or HDF with FX8 or FX 80 Helyxone during the whole study periodIn order to estimate the normal ranges of the parameters that we evaluated 60 anonymous healthy volunteers were also submitted to the same assays
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