Vascular Access for Hemodialysis and Inflammation - Full Text View

Sponsored by:	St. Orsola Hospital
Information provided by:	St. Orsola Hospital
ClinicalTrials.gov Identifier:	NCT00850707

Purpose

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).

Condition
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850707

Locations

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

Sponsors and Collaborators

St. Orsola Hospital

More Information

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.

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

Keywords provided by St. Orsola Hospital:

AVF
AVG
TCC
inflammation
monocite senescence

Study placed in the following topic categories:

Fistula
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009