Chronic Kidney Failure Clinical Trial
Official title:
Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
This is an open label placebo-controlled randomized clinical trial to assess the effect of
mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Inclusion criteria: age > 18 yrs, hemodialytic treatment from at least 6 months (3 times for
week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent
central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output<500
ml/die.
Exclusion criteria: neoplastic diseases, chronic autoimmune diseases, lack of consent, solid
organ or bone marrow transplantation.
Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as
routine hemodepurative technique for end stage renal disease patients. Patients were
evaluated for adverse reaction at each dialysis section; investigators recorded intra and
extra-dialytic adverse events.
Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized
in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15
patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax,
Fresenius Medical Care, Bad Homburg, Germany) for 9 months.
Efficacy Assessments:
Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9
months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein,
Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months.
changes in RNA content of circulating microvesicles (at 3 and 6 months)
Study Duration: 9 months
Statistical Methods: Data have been analyzed according to an intention-to-treat approach.
Statistical analysis was performed using the unpaired Student t -test, ANOVA, or
Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered
significant.
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