Pilot prospective, open label, randomized, crossover, observational study t o evaluate the efficacy in removal performance by the use of Dialyzer Elisio17hX as compared to Dialyzer Elisio17M, in adult ESRD patients receiving thrice weekly hemodialysis

Almost 5 million patients with chronic kidney disease are treated by hemodialysis worldwide. Hemodialysis has been the standard treatment for patients with chronic kidney disease for more than 70 years. Hemodialysis is a treatment in which blood is pumped out from the patient and passes through an artificial kidney, called a dialyzer or and returned to the patient. As blood passes through a series of hollow fibers in the dialyzer, and a fresh dialysate passes through the dialyzer in the opposite direction on the outside of the hollow fibers. Waste products of metabolism which build up in the blood in patients with chronic kidney disease then pass from the blood into the fresh dialysate by a process of diffusion whereby molecules move from a high concentration  from the patients blood to one of low concentration the fresh dialysate Until 2013 In India only 10 percentage  of patients requiring renal replacement therapy could undergo hemodialysis due to challenges in access to the treatment. Advanced modalities of treatments such as hemodiafiltration and dialysis with high flux dialyzer remain underutilized In Japan dialyzers were classified into five types based on their clearance for B2MG with a blood flow rate of 200 ml per min and a dialysate flow rate of 500 mL per min1 Type 1 is classified as low-flux membrane dialyzers less than 10 mL/min clearance Type 2 and 3 as high-flux membrane dialyzers Less than10 to Less than 30 mL/min and less than 30 to less than 50 mL permin clearance, respectively and Type 4 and 5 as super high flux membrane dialyzers less than 50 to less than 70 mL per min and less than 70 mL per min clearance, respectively Type 4 and 5 dialyzers are also classified as high-performance membrane HPM dialyzers due to their high flux rate permeability and biocompatibility Type V dialyzers are classified as High Performance Membrane dialyzers or so-called super  high-flux dialyzers As an emerging trend the Japanese Society of Dialysis Therapy JSDT recommendations  advise the use of High Performance Membrane dialyzers in patients on hemodialysis due to their ability to improve prognosis and decrease dialysis related complications Moreover according to a 3 year prospective cohort study of 242467 patients from JSDT data super high flux dialyzers were shown improve hemodialysis patients’ mortality The current modality of dialysis using low flux dialyzer is effective in removing small solutes through diffusion but clears only negligible amounts of middle-sized solutes, which are more difficult to remove by diffusion With the emerging trend in use of high flux dialyzers the current protocol aims at removal of a wide range of middle molecule uremic toxins with minimal albumin loss. While the use of super high flux dialyzer is based on their clearance of B2MG they may cause large amount of albumin leakage since these super high flux dialyzers have larger pores in addition  they require  high quality of dialysis fluid which meets standard dialysis fluid Endotoxin level less than 0.050EU per mL Bacterial countless than  0.1 CFU per mL which further emphasizes the need to evaluate the performance of the high flux dialyzers  as compared to the other commercially available medium cut off dialysis membrane dialyzers This study would be used to assess their efficacy and other clinical outcomes such as better control of blood pressure phosphorus & anemia levels in hemodialysis patients along with improved long term  cardiovascular mortality & morbidity optimizing dialysis treatment  and improved outcomes in  patients ensuring their overall health and safety , mainly By reducing the potential risk for increased loss of residual kidney function, diabetes and cardiovascular disease  By creating an optimal balance between clearances of middle molecular weight (MW) molecules like 62  microglobulin and myoglobin and retention of albumin thereby providing good quality of dialysis treatment to both standard & vulnerable patient