Skip to main content
OpenTrials
Completed

NCT Number: NCT00850707

Vascular Access for Hemodialysis and Inflammation

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vascular Access for Hemodialysis and Inflammation Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nephrology Dialysis Transplantation Unit St.Orsola University Hospital

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. serological markers of inflammation (CRP, IL-6, TNF-a)

    Time frame: 6 weeks

  2. monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.

    Time frame: 6 weeks

  3. monocytic cells expressing a senescent phenotype (CD14 and CD32).

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2006
Study completion
2008
First posted
Feb 25, 2009
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.