Lixivaptan BALANCE study is a 650-patient Phase III, global, multi-center, randomized, placebo-controlled, double-blind, study of lixivaptan for hyponatremia in patients with heart failure. The primary objective is to evaluate the safety and effectiveness of lixivaptan, when compared to the placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. In previous studies, lixivaptan improved blood sodium levels, lowered body weight and increased urine volume. Those studies suggest that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with heart failure, Syndrome of Inappropriate Anti-Diuretic Hormone(SIADH), and Liver Cirrhosis with
Human error assessment and reduction technique Human error assessment and reduction technique Human error assessment and reduction technique (HEART) is a technique used in the field of human reliability assessment (HRA), for the purposes of evaluating the probability of a human error occurring throughout the completion of a specific task. From such analyses measures can then be taken to reduce the likelihood of errors occurring within a system and therefore lead to an improvement in the overall levels of safety. There exist three primary reasons for conducting an HRA; error identification, error quantification and error reduction. As there exist a number of techniques used for such