Vascular Access for Hemodialysis and Inflammation - Tabular View

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Tracking Information
First Received Date ^†	February 24, 2009
Last Updated Date	February 26, 2009
Start Date ^†	January 2000
Current Primary Outcome Measures ^† (submitted: February 24, 2009)	serological markers of inflammation (CRP, IL-6, TNF-a) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] monocytic cells expressing a senescent phenotype (CD14 and CD32). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00850707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	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
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: the levels of serological markers of inflammation (CRP, IL-6, TNF-a); the degree of expression on monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44. 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.
Study Phase
Study Type ^†	Observational
Study Design ^†	Case Control, Prospective
Condition ^†	Vascular Access for Hemodialysis and Inflammation
Intervention ^†
Study Arms / Comparison Groups	220 hemodialysis patients with Arterovenous fistula (AVF group) 58 hemodialysis patients with Arterovenous graft (AVG group) 180 hemodialysis patients with Tunneled cuffed catheters (TCC group) 60 healthy subjects as controls
Publications *	Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. Review. Weiss MF, Scivittaro V, Anderson JM. Oxidative stress and increased expression of growth factors in lesions of failed hemodialysis access. Am J Kidney Dis. 2001 May;37(5):970-80. Nilsson B, Ekdahl KN, Mollnes TE, Lambris JD. The role of complement in biomaterial-induced inflammation. Mol Immunol. 2007 Jan;44(1-3):82-94. Epub 2006 Aug 14. Review. Bologa RM, Levine DM, Parker TS, Cheigh JS, Serur D, Stenzel KH, Rubin AL. Interleukin-6 predicts hypoalbuminemia, hypocholesterolemia, and mortality in hemodialysis patients. Am J Kidney Dis. 1998 Jul;32(1):107-14. Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C. Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. Kidney Int. 1999 Feb;55(2):648-58. Yeun JY, Levine RA, Mantadilok V, Kaysen GA. C-Reactive protein predicts all-cause and cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):469-76. Ramírez R, Carracedo J, Soriano S, Jiménez R, Martín-Malo A, Rodríguez M, Blasco M, Aljama P. Stress-induced premature senescence in mononuclear cells from patients on long-term hemodialysis. Am J Kidney Dis. 2005 Feb;45(2):353-9. Carracedo J, Ramírez R, Madueño JA, Soriano S, Rodríguez-Benot A, Rodríguez M, Martín-Malo A, Aljama P. Cell apoptosis and hemodialysis-induced inflammation. Kidney Int Suppl. 2002 May;(80):89-93. Review. Kielian TL, Blecha F. CD14 and other recognition molecules for lipopolysaccharide: a review. Immunopharmacology. 1995 Apr;29(3):187-205. Review. Patiño R, Ibarra J, Rodriguez A, Yagüe MR, Pintor E, Fernandez-Cruz A, Figueredo A. Circulating monocytes in patients with diabetes mellitus, arterial disease, and increased CD14 expression. Am J Cardiol. 2000 Jun 1;85(11):1288-91. Ramirez R, Carracedo J, Berdud I, Carretero D, Merino A, Rodríguez M, Tetta C, Martín-Malo A, Aljama P. Microinflammation in hemodialysis is related to a preactivated subset of monocytes. Hemodial Int. 2006 Jan;10 Suppl 1:S24-7. Tacke F, Randolph GJ. Migratory fate and differentiation of blood monocyte subsets. Immunobiology. 2006;211(6-8):609-18. Epub 2006 Jul 10. Review. Puré E, Cuff CA. A crucial role for CD44 in inflammation. Trends Mol Med. 2001 May;7(5):213-21. Review. Gee K, Lim W, Ma W, Nandan D, Diaz-Mitoma F, Kozlowski M, Kumar A. Differential regulation of CD44 expression by lipopolysaccharide (LPS) and TNF-alpha in human monocytic cells: distinct involvement of c-Jun N-terminal kinase in LPS-induced CD44 expression. J Immunol. 2002 Nov 15;169(10):5660-72. Movilli E, Brunori G, Camerini C, Vizzardi V, Gaggia P, Cassamali S, Scolari F, Parrinello G, Cancarini GC. The kind of vascular access influences the baseline inflammatory status and epoetin response in chronic hemodialysis patients. Blood Purif. 2006;24(4):387-93. Epub 2006 Jun 1. Chang CJ, Ko YS, Ko PJ, Hsu LA, Chen CF, Yang CW, Hsu TS, Pang JH. Thrombosed arteriovenous fistula for hemodialysis access is characterized by a marked inflammatory activity. Kidney Int. 2005 Sep;68(3):1312-9. Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. Beathard GA, Urbanes A. Infection associated with tunneled hemodialysis catheters. Semin Dial. 2008 Nov-Dec;21(6):528-38. Epub 2008 Sep 24. Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-57. Review. Ayus JC, Sheikh-Hamad D. Silent infection in clotted hemodialysis access grafts. J Am Soc Nephrol. 1998 Jul;9(7):1314-7. Roy-Chaudhury P, Kelly BS, Miller MA, Reaves A, Armstrong J, Nanayakkara N, Heffelfinger SC. Venous neointimal hyperplasia in polytetrafluoroethylene dialysis grafts. Kidney Int. 2001 Jun;59(6):2325-34. Oliver MJ, Mendelssohn DC, Quinn RR, Richardson EP, Rajan DK, Pugash RA, Hiller JA, Kiss AJ, Lok CE. Catheter patency and function after catheter sheath disruption: a pilot study. Clin J Am Soc Nephrol. 2007 Nov;2(6):1201-6. Epub 2007 Oct 17. Daneshian M, Wendel A, Hartung T, von Aulock S. High sensitivity pyrogen testing in water and dialysis solutions. J Immunol Methods. 2008 Jul 20;336(1):64-70. Epub 2008 Apr 24.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	458
Completion Date	December 2008
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
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.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	Italy
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00850707
Responsible Party	Prof.Sergio Stefoni, St.Orsola University Hospital
Secondary IDs ^††
Study Sponsor ^†	St. Orsola Hospital
Collaborators ^††
Investigators ^†
Information Provided By	St. Orsola Hospital
Verification Date	February 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.