Collaborative Research on HFR High Flux
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the serum concentrations of antoxidant vitamines A,
      C, E, inflammatory cytokines and middle-large toxins in patients treated with online
      hemodiafiltration, standard HFR and SUPRA-HFR.
    

Detailed description: 
      Today, as the research work of EUTOX group highlights, large cytokines and protein-bound
      solutes are gaining a relevant attention because of their emerging role as mortality
      predictors.

      Online hemodiafiltration (online HDF) has demonstrated to offer a significant depuration for
      small and middle toxins, but removal of protein-bound solutes is scarce. Synthetic high-flux
      membranes do not allow infact significant removal of molecules heavier than 15-20 KDa.
      Super-flux membranes may enhance online HDF convective transport but it would surely expose
      the patient to unacceptable losses of albumin, vitamines and aminoacids because of the non
      selectivity of the convective transport.

      HFR is a renal replacement therapy that utilizes convection, diffusion and adsorption. It
      uses a double-stage filter that consists of a high-flux polyethersulfone hemofilter in the
      first convective stage and a low-flux polyethersulfone filter in the second diffusive stage.
      The stages of the filter allow complete separation of convection from diffusion. The
      convective part of the first stage allows pure ultrafiltrate (UF) to pass through a sorbent
      resin cartridge. The first convective/adsorption stage has no net fluid removal. The blood
      and reinfused clean UF then undergo traditional dialysis. The second stage works by
      classicaHD and in this final stage the weight loss occurs. HFR has demonstrated in various
      clinical trials to reduce the microinflammatory state with no albumin loss and minimal
      aminoacids losses, thanks to the high selectivity of the resin sorbent.

      SUPRA-HFR is a newly developed HDF therapy based on the HFR concept scheme, which includes a
      super-flux membrane in the first section, coupled with an empowered resin sorbent. This
      should significantly enhance large solutes depuration, overcoming online HDF flaws.

      Therefore we proposed a prospective, multicenter, randomized study comparing online HDF,
      standard HFR and SUPRA-HFR. After a wash-out stabilization period of 4 months in
      post-dilution online HDF, an expected number of 50 patients will be randomized either in
      standard HFR (25) or in SUPRA-HFR (25) and followed for 6 months. Primary end points focus on
      the the removal of protein-bound solutes, inflammation and nutritional state. In addition,
      ESAs doses and hemoglobin levels will be assessed and compared between treatment groups.

      This study will provide strong evidence on the safe and clinically effective use of
      super-flux membranes, introduced with SUPRA-HFR therapy. It is highly likely that the
      outcomes of this study will affect the daily clinical practice of Italian and European
      dialysis centers because of the potential innovation brought to the market.

      The following hypotheses will be tested:

        -  SUPRA-HFR selectivity will reduce consistently the albumin, aminoacids and vitamines A,
           C, E losses compared to online HDF.

        -  SUPRA-HFR better preservation of the nutritional parameters, coupled with the
           possibility to remove protein-bound toxins and cytokines should lead to a higher
           reduction of the microinflammatory status, compared to online HDF and to standard HFR.

        -  SUPRA-HFR impact on inflammation status should ameliorate the anemia management by
           reducing the administered ESAs doses.
    

Intervention name(s): SUPRA-HFR
Intervention type(s): Device
Intervention description(s): usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SUPRA-HFR; adsorpition; vitamins; large toxins