Systems Engineering of Pheresis Intervention for Sepsis

描述（由申请人提供）： 回应：PAR-04-023，我们提议建立一个生物工程研究合作伙伴关系，根据血液吸附原理设计和测试用于治疗严重脓毒症的体外装置。我们的多学科团队包括基础科学和临床研究人员、生物工程和生物材料专家以及复杂系统建模专家。我们的提案将仔细整合来自技术和生物医学领域的这一多样化的研究人员群体，跨越多个科学学科的界限，并利用工业界和学术界的能力。我们的项目名为系统工程的单采干预败血症（SEPsIS）。 严重脓毒症（感染环境中急性发作的器官衰竭）是一个主要的健康问题，每年导致近25万美国人死亡，花费数十亿美元。现有的脓毒症治疗方法，包括最近批准的治疗方法，都不理想，迫切需要新的治疗方法。然而，炎症反应网络的复杂性和临床试验的高成本，特别是在重症患者中，使得传统的药物/器械开发范式过时。我们之前已经开发并测试了一种用于治疗慢性肾脏疾病的体外血液净化设备，并将该设备用于治疗急性炎症性疾病。我们还在啮齿动物和人类中开发并部分校准了败血症的数学模型。本项目建议将这两项成果结合起来，通过迭代设计过程，开发一种可用于治疗严重脓毒症的器械。 本提案的目的是设计一种用于治疗严重脓毒症的体外血液净化装置。该提案将汇集匹兹堡大学以下部门的研究人员：生物工程，化学工程，重症监护医学，外科，医学和数学。我们还将拜访两家公司的专业知识，一家专门从事吸附剂聚合物技术（MedaSorb Technologies，LLC），另一家从事复杂系统建模（Immunetrics，Inc.）。

DESCRIPTION (provided by applicant): In response to: PAR-04-023, we are proposing a Bioengineering Research Partnership to design and test an extracorporeal device for the treatment of severe sepsis, based on the principle of hemoadsorption. Our multidisciplinary team comprises basic science and clinical researchers, bioengineering and biomaterials experts, and experts in complex systems modeling. Our proposal will carefully integrate this diverse group of researchers from both technical and biomedical fields, crossing the boundaries of multiple scientific disciplines and leveraging the capabilities of both industry and academia. Our project is entitled Systems Engineering of a Pheresis Intervention for Sepsis (SEPsIS). Severe sepsis (acute onset organ failure in the setting of infection) is a major health problem that kills nearly 250,000 Americans each year and costs billions of dollars. Available therapies for sepsis, including those recently approved, are suboptimal and new therapies are urgently needed. However, the complexities of the inflammatory response network and the high cost of clinical trials, particularly in the critically ill, renders the traditional drug/device development paradigm obsolete. We have previously developed and tested an extracorporeal blood purification device for treatment in chronic renal disease and have adapted this device for the treatment of acute inflammatory diseases. We have also developed and partially calibrated-in both rodents and humans-a mathematical model of sepsis. This project proposes to integrate these two achievements and, through an iterative design process, develop a device that can be used to treat severe sepsis. The goal of this proposal is to design an extracorporeal blood purification device for the treatment of severe sepsis. This proposal will bring together investigators from the following departments at the University of Pittsburgh: Bioengineering, Chemical Engineering, Critical Care Medicine, Surgery, Medicine, and Mathematics. We will also call on the expertise of two companies, one specializing in adsorbent polymer technology (MedaSorb Technologies, LLC) and the other in complex systems modeling (Immunetrics, Inc.).