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.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23GM076652-05
Application #
7903110
Study Section
Surgery, Anesthesiology and Trauma Study Section (SAT)
Program Officer
Somers, Scott D
Project Start
2006-08-01
Project End
2011-07-31
Budget Start
2010-08-01
Budget End
2011-07-31
Support Year
5
Fiscal Year
2010
Total Cost
$119,610
Indirect Cost
Name
Carolinas Medical Center
Department
Type
DUNS #
074524513
City
Charlotte
State
NC
Country
United States
Zip Code
28232
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Puskarich, Michael A; Jones, Alan E (2014) Clearing lactate is clearly better…but how much?*. Crit Care Med 42:2149-50
Jones, Alan E (2013) Lactate clearance for assessing response to resuscitation in severe sepsis. Acad Emerg Med 20:844-7
Puskarich, Michael A; Trzeciak, Stephen; Shapiro, Nathan I et al. (2013) Whole blood lactate kinetics in patients undergoing quantitative resuscitation for severe sepsis and septic shock. Chest 143:1548-1553
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Puskarich, Michael A; Shapiro, Nathan I; Trzeciak, Stephen et al. (2012) Plasma levels of mitochondrial DNA in patients presenting to the emergency department with sepsis. Shock 38:337-40
Puskarich, Michael A; Trzeciak, Stephen; Shapiro, Nathan I et al. (2012) Prognostic value and agreement of achieving lactate clearance or central venous oxygen saturation goals during early sepsis resuscitation. Acad Emerg Med 19:252-8

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