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Vascular Access for Hemodialysis and Inflammation

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ClinicalTrials.gov Identifier: NCT00850707
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
St. Orsola Hospital

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).

Condition or disease
Vascular Access for Hemodialysis and Inflammation

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.


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Study Type : Observational
Actual Enrollment : 458 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Artero-Venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation
Study Start Date : January 2000
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850707


Locations
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Italy
Nephrology Dialysis Transplantation Unit St.Orsola University Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital

Publications:

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Responsible Party: Prof.Sergio Stefoni, St.Orsola University Hospital
ClinicalTrials.gov Identifier: NCT00850707     History of Changes
Other Study ID Numbers: VASACC2009-02
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009
Keywords provided by St. Orsola Hospital:
AVF
AVG
TCC
inflammation
monocite senescence
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes