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

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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.