Vascular Access for Hemodialysis and Inflammation

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Vascular Access for Hemodialysis and Inflammation

Study type: Observational

Funder types: Other

Identifiers

NCT00850707

VASACC2009-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 458 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

458 participants in 4 patient groups

1

Description:

220 hemodialysis patients with Arterovenous fistula (AVF group)

2

Description:

58 hemodialysis patients with Arterovenous graft (AVG group)

3

Description:

180 hemodialysis patients with Tunneled cuffed catheters (TCC group)

4

Description:

60 healthy subjects as controls