Development of the New Kibou® Equipment for Continuous Renal Replacement Therapy from Scratch to the Final Configuration.

A new technology has recently appeared in the area of extracorporeal therapies for critically ill patients with acute kidney injury. The International Renal Research Institute of Vicenza was involved from the beginning in the development of a new continuous renal replacement therapy (CRRT) equipment with peculiar characteristics. We report the overall experience from design of the new machine to its in vitro and in vivo testing. Kibou® (Asahi Kasei Kuraray Medical Co., Ltd., Tokyo, Japan) is a new multifunctional machine designed for delivering RRT. Kibou® carries out many features of the fourth generation CRRT machines including the possibility of a dynamic prescription and reduction of nursing workload. We describe our first experience with this new device, focusing on several usability and performance parameters. A specific in vitro protocol was designed to analyze the various characteristics and accuracy of performance of the machine. Furthermore, a preliminary in vivo alpha trial with 12 CRRT sessions was performed to test, characterize and evaluate the machine in terms of usability, flexibility and reliability. The in vitro evaluation confirmed an adequate design and a good usability of the machine with accurate delivery of prescribed parameters. No adverse events were observed during the in vivo test that confirmed usability and safety together with accuracy of treatment delivery in different modalities. In general, the machine was rated by physicians and nurses involved in the evaluation as practical and easy to use, although a specific training is required to familiarize with the equipment. A large-scale multicenter beta trial is required to confirm the results reported in this preliminary evaluation in terms of safety, accuracy and performance of Kibou®.