Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 10, 2014

Detailed Description

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.

Interventions

  • Procedure: mixed on-line hemodiafiltration
    • This is a mixed hemodepurative technique exploiting diffusion and convection through a semi-permeable membrane. Dialysis solution is not only interfacing with blood through the membrane (as in bicarbonate hemodialysis) but it is also mixed with it with a pre- and a post- filter dilution. The same amount of fluid added to the bloodstream is then removed within the filter through an appropriate negative pressure in the dialysis solution compartment and thanks a high permeability membrane. Patients will be treated three sessions per week, four hours per session
  • Procedure: High flux bicarbonate dialysis
    • Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session

Arms, Groups and Cohorts

  • Experimental: Mixed on-line hemodiafiltration
    • Mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany), three sessions per week, four hours per session
  • Active Comparator: High flux bicarbonate dialysis
    • Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session

Clinical Trial Outcome Measures

Primary Measures

  • RNA content of circulating particles
    • Time Frame: Study start (time 0) and study end (9 months)
    • Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR

Secondary Measures

  • Circulating inflammatory markers
    • Time Frame: All the study timepoints: time 0 and 3, 6, 9 months
    • Quantitative changes in C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin
  • RNA content of circulating particles
    • Time Frame: All the study timepoints: time 0 and 3, 6, 9 months
    • Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR

Participating in This Clinical Trial

Inclusion Criteria

  • hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (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, autoimmune diseases, solid organ or bone marrow transplantation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vincenzo Cantaluppi, Principal investigator – Associate Professor of Nephrology – Azienda Ospedaliera Città della Salute e della Scienza di Torino

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