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

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).

Study Overview

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 Type

Observational

Enrollment (Actual)

458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bologna, Italy, 40138
        • Nephrology Dialysis Transplantation Unit St.Orsola University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The three groups of patients were homogeneous for: a) demographic characteristics; b) dialysis adequacy; c) vascular access blood flow; d) white cell count.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
220 hemodialysis patients with Arterovenous fistula (AVF group)
2
58 hemodialysis patients with Arterovenous graft (AVG group)
3
180 hemodialysis patients with Tunneled cuffed catheters (TCC group)
4
60 healthy subjects as controls

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VASACC2009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Access for Hemodialysis and Inflammation

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