Vascular Access for Hemodialysis and Inflammation
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|ClinicalTrials.gov Identifier: NCT00850707|
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : February 27, 2009
The aim of the present study was to investigate patients free of active infection and/or thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:
- the levels of serological markers of inflammation (CRP, IL-6, TNF-a);
- the degree of expression on monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
- the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).
|Condition or disease|
|Vascular Access for Hemodialysis and Inflammation|
Patients with AVF assumed ticlopidine 250 mg/die, patients with TCC and AVG assumed warfarin to maintain target INR between 1.8 and 2.5.
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 period.In order to estimate the normal ranges of the parameters that we evaluated, 60 anonymous healthy volunteers were also submitted to the same assays.
|Study Type :||Observational|
|Actual Enrollment :||458 participants|
|Observational Model:||Case Control|
|Official Title:||Artero-Venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2008|
220 hemodialysis patients with Arterovenous fistula (AVF group)
58 hemodialysis patients with Arterovenous graft (AVG group)
180 hemodialysis patients with Tunneled cuffed catheters (TCC group)
60 healthy subjects as controls
- serological markers of inflammation (CRP, IL-6, TNF-a) [ Time Frame: 6 weeks ]
- monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44. [ Time Frame: 6 weeks ]
- monocytic cells expressing a senescent phenotype (CD14 and CD32). [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850707
|Nephrology Dialysis Transplantation Unit St.Orsola University Hospital|
|Bologna, Italy, 40138|