Sergio Dellepiane1, Marita Marengo2, Mario D'Arezzo3, Gabriele Donati4, Paolo Fabbrini5, Antonio Lacquaniti6, Claudio Ronco7,8, Vincenzo Cantaluppi9. 1. Department of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 2. Nephrology and Dialysis Unit, ASL CN1, Cuneo, Italy. 3. Nephrology, Dialysis and Kidney Transplant Unit, Ospedali Riuniti - Ancona University Hospital, Ancona, Italy. 4. Nephrology Dialysis and Renal Transplantation Unit, St. Orsola University Hospital, Bologna, Italy. 5. Nephrology and Dialysis Unit, San Gerardo Hospital and Milano Bicocca University, Monza, Italy. 6. Nephrology and Dialysis Unit, Papardo Hospital, Messina, Italy. 7. Department of Medicine, University of Padova, Padova, Italy. 8. Division of Nephrology, Dialysis and Kidney Transplantation Unit, International Renal Research Institute Vicenza (IRRIV), "San Bortolo" Hospital, Vicenza, Italy. 9. Nephrology and Kidney Transplantation Unit, Department of Translational Medicine, University of Piemonte Orientale (UPO), "Maggiore della Carità" University Hospital, Novara, Italy.
Abstract
INTRODUCTION: Impact assessment of new technologies in chronic hemodialysis (HD) is challenging due to HD patient frailty, the complexity of HD clinical trials and practice variability among countries. Among the most recent HD innovations, medium cut-off (MCO) dialyzers present an optimized membrane geometry that provides enhanced clearances for middle and large molecular weight uremic toxins (UT). These toxins are poorly cleared by available HD techniques and largely contribute to patient morbidity and mortality. The aim of this paper is to assess the available clinical evidence about MCO membranes and to identify the next steps needed to generate conclusive data on their use in HD. METHODS: With this purpose, we first reviewed and compared the current HD technologies aimed to improve the clearance of middle and large UT; subsequently, we used a Delphi questionnaire to identify and discuss the consensus about MCO efficacy within a large sample of the Italian Nephrology community. RESULTS AND CONCLUSIONS: Our investigation gathered a significant degree of consensus on the beneficial role of MCO membrane and expanded HD. Finally, we used our results to propose future trial designs and clinical investigations aimed to improve evidence quality about the use of these membranes in the present clinical scenario of dialysis units.
INTRODUCTION: Impact assessment of new technologies in chronic hemodialysis (HD) is challenging due to HD patient frailty, the complexity of HD clinical trials and practice variability among countries. Among the most recent HD innovations, medium cut-off (MCO) dialyzers present an optimized membrane geometry that provides enhanced clearances for middle and large molecular weight uremic toxins (UT). These toxins are poorly cleared by available HD techniques and largely contribute to patient morbidity and mortality. The aim of this paper is to assess the available clinical evidence about MCO membranes and to identify the next steps needed to generate conclusive data on their use in HD. METHODS: With this purpose, we first reviewed and compared the current HD technologies aimed to improve the clearance of middle and large UT; subsequently, we used a Delphi questionnaire to identify and discuss the consensus about MCO efficacy within a large sample of the Italian Nephrology community. RESULTS AND CONCLUSIONS: Our investigation gathered a significant degree of consensus on the beneficial role of MCO membrane and expanded HD. Finally, we used our results to propose future trial designs and clinical investigations aimed to improve evidence quality about the use of these membranes in the present clinical scenario of dialysis units.