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Sponsored by: |
St. Orsola Hospital |
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Information provided by: | St. Orsola Hospital |
ClinicalTrials.gov Identifier: | NCT00850707 |
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:
Condition |
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Vascular Access for Hemodialysis and Inflammation |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Artero-Venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation |
Enrollment: | 458 |
Study Start Date: | January 2000 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
220 hemodialysis patients with Arterovenous fistula (AVF group)
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2
58 hemodialysis patients with Arterovenous graft (AVG group)
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3
180 hemodialysis patients with Tunneled cuffed catheters (TCC group)
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4
60 healthy subjects as controls
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
The three groups of patients were homogeneous for: a) demographic characteristics; b) dialysis adequacy; c) vascular access blood flow; d) white cell count.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | St.Orsola University Hospital ( Prof.Sergio Stefoni ) |
Study ID Numbers: | VASACC2009-02 |
Study First Received: | February 24, 2009 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00850707 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
AVF AVG TCC inflammation monocite senescence |
Fistula Inflammation |
Pathologic Processes Inflammation |