Clinical trial NCT00850707: Vascular Access for Hemodialysis and Inflammation
Official title: Artero-venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access for Hemodialysis and Inflammation
Keywords: AVF
AVG
TCC
inflammation
monocite senescence
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: serological markers of inflammation (CRP, IL-6, TNF-a)
timeFrame: 6 weeks
measure: monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
timeFrame: 6 weeks
measure: monocytic cells expressing a senescent phenotype (CD14 and CD32).
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Nephrology Dialysis Transplantation Unit St.Orsola University Hospital
Study officials:
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