Studies performed with phase I SBIR grants 1R43DK55385-01A1 and 1 R43 DK59062-01A1 and phase II SBIR grants 2R44DK059062-02A1 and 5R44DK059062-04 have demonstrated the following: a) A new hemodialysis(HD) venous needle (NVN) with three jets is hemodynamically superior to the current venous needle (CVN) because it decreases the velocity of the vascular access flow by 3.5 times and the turbulence by 6 times when compared with the currently used venous needle (CVN), and unlike the CVN, it does not form an area of annular recirculation. b) The NVN is more efficient than the CVN in the removal of BUN, it is safe(it causes equal or less damage to cells, it does not form clots and does not cause prolonged bleeding at puncture sites), and it is as effective as the CVN to fulfills the function of conduit to transport blood. c) More importantly, the data from HD in sheep and patients suggest that the NVN is clinically superior to the CVN because it causes less damage to circulating blood cells and less generation and release of cytokines and oxidants. However, the data did not show statistically significant superiority because the sample size was small. The proposed phase II competing renewal grant will demonstrate clinical superiority of the NVN by studying a larger number of HD patients and obtaining statistically significant data. Seventy stable HD patients will be studied. Each patient will receive one mid-week HD using the CVN and one mid-week HD using the NVN the following week. Pre and post HD plasma and intracellular IL-1 and IL-6, intracellular IL-6 soluble receptor, IL-6 gp130, superoxide and hydrogen peroxide and plasma Mandenyldealdehyde(MDA) and advanced oxidation protein products(AOPP) will be measured. Each patient will use the same HD prescription during both HD including length of dialysis, type of dialyzer non-reused, size of needles (15g), heparin, dialysate composition, and blood and dialysate flow rate. The outcomes to be compared are net changes in blood levels of all the markers in the NVN and CVN groups. Demonstrating that the NVN is clinically superior will have great significance: a) It will show that the NVN is more useful than the CVN: The NVN would decrease the complications caused by inflammation and oxidative stress, the mortality of patients and the cost of care, b) It will allow claiming clinical superiority of the NVN in the application for pre-market approval to be submitted to the FDA. This will facilitate marketing and sales and is necessary to obtain investments to commercialize the needle. The NVN fills a technological gap and a clinical need: the CVN is not fit for use with the 400-500 ml/min blood flow rates currently used in HD. The NVN is protected by several patents and the process to obtain a 510K from the FDA has been started.
"""""""" This project will demonstrate that the new venous needle (NVN) is a product that will help hemodialysis patients unlike the current venous needle (CVN) that is harmful to patients. The NVN will decrease medical complications, mortality and the cost of care of hemodialysis patients. """""""" The NVN fills a technological gap and a clinical need: The current venous needle (CVN) fulfills the needs of hemodialysis with low blood flow rates but it is not fit for use with the high blood flow rate currently used of 400-500 ml/min. """""""" This study will enhance scientific knowledge to improve the delivery of dialysis and the design of devices used on dialysis.
