Vascular Access for Hemodialysis and Inflammation

Vascular Access for Hemodialysis and Inflammation Clinical Trial

Official title:

Artero-venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850707
• Other study ID #: VASACC2009-02
• Status: Completed
• Start date: January 2000
• Est. completion date: December 2008

Study information

• Verified date: March 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: December 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Vascular Access for Hemodialysis and Inflammation

Locations

Country	Name	City	State
Italy	Nephrology Dialysis Transplantation Unit St.Orsola University Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (23)

Ayus JC, Sheikh-Hamad D. Silent infection in clotted hemodialysis access grafts. J Am Soc Nephrol. 1998 Jul;9(7):1314-7. — View Citation

Beathard GA, Urbanes A. Infection associated with tunneled hemodialysis catheters. Semin Dial. 2008 Nov-Dec;21(6):528-38. doi: 10.1111/j.1525-139X.2008.00497.x. Epub 2008 Sep 24. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.jim.2008.03.013. Epub 2008 Apr 24. — View Citation

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. — View Citation

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. — View Citation

Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-57. Review. — View Citation

Kielian TL, Blecha F. CD14 and other recognition molecules for lipopolysaccharide: a review. Immunopharmacology. 1995 Apr;29(3):187-205. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Puré E, Cuff CA. A crucial role for CD44 in inflammation. Trends Mol Med. 2001 May;7(5):213-21. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tacke F, Randolph GJ. Migratory fate and differentiation of blood monocyte subsets. Immunobiology. 2006;211(6-8):609-18. Epub 2006 Jul 10. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serological markers of inflammation (CRP, IL-6, TNF-a)		6 weeks
Primary	monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.		6 weeks
Primary	monocytic cells expressing a senescent phenotype (CD14 and CD32).		6 weeks