Randomized Clinical Trial of a Less-Invasive Resuscitation Protocol for Sepsis

描述(由申请人提供)：本提案详细说明了以患者为中心的临床研究中结构化的指导性培训计划。PI已经完成了急诊医学和临床研究奖学金的实习，并正在寻求这一奖项，以完成指导研究培训和研究教学教育的密集经验，以实现以下职业目标：1)实现独立研究资金，目的2)在急诊科(ED)治疗严重脓毒症和感染性休克领域进行重要调查。该项目包括为期5年的课程，包括三个不同的培训阶段，包括：1)指导-Jeffrey Kline博士是项目导师。他是一名由美国国立卫生研究院资助的研究员，他将确保及时有效地应用通过课程学习和研究经验获得的知识。其他导师包括一名职业发展导师、一名外部项目导师和一名统计学导师；2)教学学-将获得临床流行病学和卫生服务研究理学硕士学位，该学位将极大地丰富PI研究奖学金中启动的方法学知识库和研究技能；3)调查-该奖项的研究计划旨在测试以下假设：在患有严重败血症和感染性休克的ED患者中，侵入性较小的目标导向复苏方案等同于完全侵入性目标导向复苏方案。脓毒症是一种主要的公共卫生危机，其发病率每年以1.5%的速度递增，每年导致21.5万人死亡，美国每年花费167亿美元的卫生保健资源。先前的工作表明，在急诊室进行全侵入性目标定向复苏可以显著降低严重脓毒症和感染性休克的住院死亡率和医院资源。不幸的是，该方案复杂、侵入性强且成本高昂。在一项随机临床试验中，我们将通过用乳酸清除量代替中心静脉血氧饱和度测量来比较这种完全侵入性方案与侵入性较小方案的住院死亡率等效性。这个项目的相关性在于它对公众健康的好处，因为它提供了一种更简单、更便宜、更容易被接受和应用于临床的侵入性较小的复苏方案。这可能会导致每年挽救数千人的生命，并降低脓毒症患者的护理成本。

DESCRIPTION (provided by applicant): This proposal details a structured mentored training program in patient-oriented clinical research. The PI has completed a residency in emergency medicine and a clinical research fellowship and is seeking this award to complete an intensive experience of mentored research training and research didactic education to achieve the career goals of 1) achieving independent research funding for the purpose of 2) conducting significant investigations in the area of emergency department (ED) treatment of severe sepsis and septic shock. This project includes a 5 year curriculum with three distinct phases of training including: 1) Mentoring - Dr. Jeffrey Kline is the project mentor. He is an NIH-funded investigator who will ensure timely and effective application of the knowledge gained through coursework and research experience. Other mentors include a career development mentor, an external project mentor, and a statistical mentor; 2) Didactics - A Masters of Science in Clinical Epidemiology and Health Services Research will be obtained and this degree will significantly enrich the methodological knowledge base and research skills initiated in the Pi's research fellowship; 3) Investigation - The research program in this award seeks to test the hypothesis that a less- invasive goal-directed resuscitation protocol is equivalent to a fully invasive goal-directed resuscitation protocol in ED patients with severe sepsis and septic shock. Sepsis is a major public health crisis whose incidence is increasing by 1.5% per annum, results in 215,000 deaths per year and costs the United States $16.7 billion dollars in health care resources per year. Previous work has suggested that fully invasive goal- directed resuscitation in the ED could substantially reduce the in-hospital mortality and hospital resources in severe sepsis and septic shock. Unfortunately the protocol is complicated, invasive and expensive. In a randomized clinical trial we will compare for hospital mortality equivalence this fully invasive protocol to a less-invasive protocol by replacing central venous oximetry measurements with lactate clearance measurements. The relevance of this project lies in its benefit to public health of providing a less-invasive resuscitation protocol that will be simpler, cheaper and thus more accepted and applied to clinical practice. This will potentially result in saving thousands of lives per year and reduce the cost of care for septic patients.