Vascular Access for Hemodialysis and Inflammation
17. mars 2021 oppdatert av: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Artero-venous Fistula, Prosthetic Polytetrafluoroethylene Grafts (AVG), Tunneled Cuffed Catheter (TCC): Impact of Vascular Access on HD Inflammation and Monocyte Activation
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).
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
458
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Bologna, Italia, 40138
- Nephrology Dialysis Transplantation Unit St.Orsola University Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The three groups of patients were homogeneous for: a) demographic characteristics; b) dialysis adequacy; c) vascular access blood flow; d) white cell count.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serological markers of inflammation (CRP, IL-6, TNF-a)
Tidsramme: 6 weeks
|
6 weeks
|
|
monocyte surface of inflammation and immune response modulating molecules: CD14, CD32 and CD44.
Tidsramme: 6 weeks
|
6 weeks
|
|
monocytic cells expressing a senescent phenotype (CD14 and CD32).
Tidsramme: 6 weeks
|
6 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. doi: 10.1016/j.ajkd.2003.07.016.
- 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. doi: 10.1093/infdis/168.2.400.
- 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. doi: 10.1016/s0272-6386(00)70200-9.
- 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. doi: 10.1053/ajkd.1998.v32.pm9669431.
- 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. doi: 10.1016/s0272-6386(05)80013-7.
- 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. doi: 10.1016/j.molimm.2006.06.020. Epub 2006 Aug 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. doi: 10.1046/j.1523-1755.1999.00273.x.
- Ramirez R, Carracedo J, Soriano S, Jimenez R, Martin-Malo A, Rodriguez 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. doi: 10.1053/j.ajkd.2004.10.022.
- Carracedo J, Ramirez R, Madueno JA, Soriano S, Rodriguez-Benot A, Rodriguez M, Martin-Malo A, Aljama P. Cell apoptosis and hemodialysis-induced inflammation. Kidney Int Suppl. 2002 May;(80):89-93. doi: 10.1046/j.1523-1755.61.s80.17.x.
- Kielian TL, Blecha F. CD14 and other recognition molecules for lipopolysaccharide: a review. Immunopharmacology. 1995 Apr;29(3):187-205. doi: 10.1016/0162-3109(95)00003-c.
- Patino R, Ibarra J, Rodriguez A, Yague 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. doi: 10.1016/s0002-9149(00)00757-8.
- Ramirez R, Carracedo J, Berdud I, Carretero D, Merino A, Rodriguez M, Tetta C, Martin-Malo A, Aljama P. Microinflammation in hemodialysis is related to a preactivated subset of monocytes. Hemodial Int. 2006 Jan;10 Suppl 1:S24-7. doi: 10.1111/j.1542-4758.2006.01186.x.
- Tacke F, Randolph GJ. Migratory fate and differentiation of blood monocyte subsets. Immunobiology. 2006;211(6-8):609-18. doi: 10.1016/j.imbio.2006.05.025. Epub 2006 Jul 10.
- Pure E, Cuff CA. A crucial role for CD44 in inflammation. Trends Mol Med. 2001 May;7(5):213-21. doi: 10.1016/s1471-4914(01)01963-3.
- 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. doi: 10.4049/jimmunol.169.10.5660.
- 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. doi: 10.1159/000093681. 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. doi: 10.1111/j.1523-1755.2005.00529.x.
- 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.
- Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-1557. doi: 10.1681/ASN.V1271549.
- Ayus JC, Sheikh-Hamad D. Silent infection in clotted hemodialysis access grafts. J Am Soc Nephrol. 1998 Jul;9(7):1314-7. doi: 10.1681/ASN.V971314.
- 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. doi: 10.1046/j.1523-1755.2001.00750.x.
- 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. doi: 10.2215/CJN.01910507. 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. doi: 10.1016/j.jim.2008.03.013. Epub 2008 Apr 24.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2000
Primær fullføring (Faktiske)
1. desember 2006
Studiet fullført (Faktiske)
1. desember 2008
Datoer for studieregistrering
Først innsendt
24. februar 2009
Først innsendt som oppfylte QC-kriteriene
24. februar 2009
Først lagt ut (Anslag)
25. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VASACC2009-02
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .