Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
458 participants
Study Classification
OBSERVATIONAL
Study Start Date
2000-01-31
Study Completion Date
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cohort Study on A Following-up System of Native Arteriovenous Fistulae
NCT02880761
Arteriovenous Fistulae
COMPLETED
NA
Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis
NCT06815159
AV Fistula
RECRUITING
NA
Endothelial Function and Arterio-Venous Fistula Maturation
NCT01604473
Chronic Kidney Disease
COMPLETED
Use of Arterio-venous Fistula as First Choice for Intravenous Drug Administration in Kidney Transplant Recipients
NCT02874391
Evaluate the Risks of Using Arteriovenous Fistula as First Choise for Drug Administration
UNKNOWN
Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients
NCT07058441
Arteriovenous Fistula Maturation Failure in End-stage Renal Disease
ACTIVE_NOT_RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Vascular Access for Hemodialysis and Inflammation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
220 hemodialysis patients with Arterovenous fistula (AVF group)
No interventions assigned to this group
2
58 hemodialysis patients with Arterovenous graft (AVG group)
No interventions assigned to this group
3
180 hemodialysis patients with Tunneled cuffed catheters (TCC group)
No interventions assigned to this group
4
60 healthy subjects as controls
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* Patients with acute cardiovascular accident in the last 15 days before starting the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
St.Orsola University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nephrology Dialysis Transplantation Unit St.Orsola University Hospital
Bologna, , Italy
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Italy
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VASACC2009-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
NCT01099189
COMPLETED
The Arteriovenous Vascular (AV) ACCESS Trial
NCT04646226
ACTIVE_NOT_RECRUITING
NA
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)
NCT04063787
COMPLETED
NA
Optimal Screening Program in Detecting Stenosis and Predicting Thrombosis in Hemodialysis Graft
NCT03839264
COMPLETED
Surveillance and Proactive Intervention for Dialysis Access
NCT01391975
WITHDRAWN
NA
Blood Flow Conditions and Sounds in AVFs
NCT06411353
RECRUITING
NA
Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
NCT05531825
RECRUITING
Correlation Between Access Blood Flow and Extracorporeal Blood Flow
NCT00522704
UNKNOWN
Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick
NCT05801549
COMPLETED
Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF
NCT04418726
UNKNOWN
NA
Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
NCT04017806
UNKNOWN
Alucent Vessel Restoration System for AVF
NCT05462223
RECRUITING
NA
Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access
NCT03701243
UNKNOWN
NA
Hemodialysis Vascular Access Imaging Study
NCT02374762
COMPLETED
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
NCT02981706
COMPLETED
NA
Arteriovenous Fistula Cannulation Practices and Dialysis Adequacy
NCT04270292
COMPLETED
The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
NCT05082792
UNKNOWN
NA
The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula
NCT05960877
UNKNOWN
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
NCT00836862
COMPLETED
Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula
NCT04164693
COMPLETED
NA
Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae
NCT04613115
COMPLETED
Ultrasound Prediction of Successful Balloon Assisted AVF Maturation
NCT06771973
NOT_YET_RECRUITING
Maximizing Native Arteriovenous Fistulae Rates.
NCT02705417
COMPLETED
Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients
NCT04011072
COMPLETED
NA
Exercise Program for Arteriovenous Fistula Maturation
NCT04034433
RECRUITING
NA