NCT00850707

Vascular Access for Hemodialysis and Inflammation

Artero-venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 458 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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: 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 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.

Conditions

• Vascular Access for Hemodialysis and Inflammation

Timeline

• Start date: 2000-01-01
• Primary completion: 2006-12-01
• Completion: 2008-12-01
• First posted: 2009-02-25
• Last updated: 2021-03-18

Locations

1 site across 1 country: Italy