Vascular Access for Hemodialysis and Inflammation

Completed

• Conditions: Vascular Access for Hemodialysis and Inflammation

• Registration Number: NCT00850707
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2006-12
• Study Completion: 2008-12
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nephrology Dialysis Transplantation Unit St.Orsola University Hospital; 🇮🇹 Bologna, Italy