Vascular Access for Hemodialysis and Inflammation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Vascular Access for Hemodialysis and Inflammation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients recruited for the study were infection and thrombosis free from almost 6 months. No patients included had autoimmune disease, hepatic failure, diabetes or malignancy. Patients were not administered ACE inhibitors, angiotensin receptor antagonists, antiinflammatory or immunosuppressive drugs. All the patients had residual GFR < 5 ml/min. The vascular access considered were placed from at least 6 months. Exclusion Criteria: Patients with recirculating vascular access > 10% were excluded from the study. Patients with acute cardiovascular accident in the last 15 days before starting the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>220 hemodialysis patients with Arterovenous fistula (AVF group) | |
| 2<br>58 hemodialysis patients with Arterovenous graft (AVG group) | |
| 3<br>180 hemodialysis patients with Tunneled cuffed catheters (TCC group) | |
| 4<br>60 healthy subjects as controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serological markers of inflammation (CRP, IL-6, TNF-a) |  | 6 weeks | 
| monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44. |  | 6 weeks | 
| monocytic cells expressing a senescent phenotype (CD14 and CD32). |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVF, AVG, TCC, inflammation, monocite senescence