Clinical Study on iNOS EIA for Sepsis and Septic Shock

描述（由申请人提供）：在开发一种高度敏感和 我们发现，对于诱导型一氧化氮合酶（iNOS）， 这种蛋白质游离于全身炎症反应患者的血浆中 综合征（SIRS）或脓毒症，但不能检测到它在血浆中获得的 健康的个体。我们的新发现使我们提出， 血浆iNOS水平的升高可作为有效的生化标志物， 明确SIRS和/或脓毒症的发作，并监测患者的 随着情况的改善或恶化。我们的目标是开发一种创新的 新的临床诊断，可以快速检测，定量和监测这一点 在严重脓毒症和脓毒性休克发作之前iNOS增加， 为未来的有害事件提供预警信号。早日 诊断将提供一个基础，为更早开始治疗比 目前实行。两项先前研究的结果表明， 可在患有以下疾病的患者中检测和测量增加的iNOS血浆水平： SIRS和/或脓毒症，发生在SIRS和/或脓毒症发作的早期，和 预测未来的问题。第二阶段项目的目标是（1）扩大 这项研究对400名患者进行了研究，以评估对两名患者的观察结果是否正确。 较小的患者队列通常是适用的，以及（2）确定是否 在SIRS和脓毒症中iNOS的血浆水平升高是唯一的 病理学和不发生在其他疾病相关的过度 iNOS的表达。一旦完成，这个项目将带来一个独特的， 需要新的临床诊断进入市场，这反过来将导致 改善危重病人的医疗保健。 拟议的商业应用： 每年有超过1，200，000例全身炎症反应综合征和脓毒症发生， 美国;这些导致超过500，000例/年的严重脓毒症和脓毒性休克以及100，000 - 250，000例/年的死亡。需要一种快速测试来评估患者进入脓毒症途径并沿着脓毒症途径进展为严重脓毒症和脓毒性休克。我们的EIA旨在满足这一临床需求，通过减少ICU住院时间来降低患者成本。并改善患者的预后。

DESCRIPTION (provided by applicant): After developing a highly sensitive and robust sandwich ETA for inducible nitric oxide synthase (iNOS), we discovered this protein free in plasma of patients with systemic inflammatory response syndrome (SIRS) or sepsis, but could not detect it in plasma obtained from healthy individuals. Our novel discovery has lead us to proposed that the increased plasma level of iNOS can serve as a valid biochemical marker to prognosticate the onset of SIRS and/or sepsis and to monitor a patient's condition as it improves or deteriorates. Our goal is to develop an innovative new clinical diagnostic that can rapidly detect, quantitate and monitor this increase in iNOS prior to the onset of severe sepsis and septic shock, and thus provide an early warning signal for future deleterious events. An early diagnosis will provide a basis for the earlier initiation of therapies than is currently practiced. The results from two prior studies indicate that an increased plasma level of iNOS can be detected and measured in patients with SIRS and/or sepsis, occurs early in an episode of SIRS and/or sepsis, and forecasts future problems. The aims of this phase 2 project are (1) to extend the study to 400 patients in order to assess if the observations made on two smaller cohorts of patients are generally applicable and (2) to determine if the increased plasma level of iNOS in SIRS and sepsis is unique to this pathology and does not occur in other diseases associated with an over expression of iNOS. Once completed, this project will bring a unique and much needed new clinical diagnostic onto the market, and this, in turn, will lead to improved health care for critically ill patients. PROPOSED COMMERCIAL APPLICATIONS: Over 1,200,000 cases/yr of systemic inflammatory response syndrome and sepsis occur in the USA; these lead to over 500,000 cases/yr of severe sepsis and septic shock and 100,000 - 250,000 deaths/yr. A rapid test to assess a patient's entry into and progress down the sepsis pathway to severe sepsis and septic shock is needed. Our EIA is designed to meet this clinical need, to lower patient cost by reducing the length of ICU stays. and to improve patient outcome.