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Innovation in Pediatric Sepsis: Is there anything new on the horizon? Derek S. Wheeler, MD, FAAP, FCCP, FCCM Associate Professor of Clinical Pediatrics University of Cincinnati College of Medicine Clinical Director, Division of Critical Care Medicine Cincinnati Children’s Hospital Medical Center The James M. Anderson Center for Health Systems Excellence Co-Director, The Center for Acute Care Nephrology Sepsis is a Common Cause of Death Top Ten Causes of Death in the U.S. 1. Heart Disease 2. Cancer 3. Stroke (Cerebrovascular Disease) 4. Chronic lower respiratory disease 5. Accidents 6. Alzheimer’s Disease 7. Diabetes 8. Influenza and Pneumonia 9. Nephritis, Nephrotic Syndrome, and Nephrosis 10. Septicemia #6 and #8 in neonatal and pediatric age group, respectively Source National Center for Health Statistics, 2007 Sepsis is a Common Cause of Death Many of these patients will die from sepsis! Sepsis is a Common Cause of Death Sepsis is #1 killer worldwide 2008 worldwide data from WHO, UNICEF, and Bill and Melinda Gates Foundation 8.8 million deaths in children <5 years of age 68% (5.97 million) due to infectious diseases Sepsis is the final common pathway in deaths from malaria, dengue fever, pneumonia, HIV/AIDS, and diarrheal illness! Lancet 2010; 375:1969 …Yet Sepsis Receives Comparably Little Funding 4000 NIH RCDC Funding 3500 8000 7000 2500 2000 1500 6000 Dollars (in millions) Dollars (in millions) 3000 Heart Disease 5000 Cancer Septicemia Stroke HIV/AIDS COPD Small Pox Accidents 4000 Alzheimer's Disease Diabetes Influenza and Pneumonia 3000 1000 Kidney Disease Septicemia 2000 500 1000 0 0 2006 2007 2006 2007 2008 2008 2009 2009 Source NIH Funding Levels for Categories Research, Condition, and Disease Categorization (RCDC) “No More Talk of Magic Bullets Please!” 1. Complexity (nonlinear) 2. Redundancy 3. Obligatory Nature Rev Drug Discovery 2003, 2:391 Key Innovations in Sepsis Sepsis recognition is inconsistent at best Early Recognition = Early Treatment = Better Outcomes Sepsis is a syndrome, not a disease Minimize heterogeneity via better definition of target populations and severity Sepsis management is highly variable Minimize variation via explicit control of co-interventions Key Innovations in Sepsis Sepsis recognition is inconsistent at best Early Recognition = Early Treatment = Better Outcomes Sepsis is a syndrome, not a disease Minimize heterogeneity via better definition of target populations and severity Sepsis management is highly variable Minimize variation via explicit control of co-interventions Innovations in Recognition Fever + Tachycardia + Risk Factor => Activation of EGDT Protocol Computerized Best Practice Alerts (4,552 triggers/39,697 visits) 81% Sensitivity 89% Specificity PPV 4% NPV 99.9% “Door to antibiotics” decreased from 143 to 38 minutes TCH Sepsis Protocol Cruz et al. Pediatrics 2011; 127:e758 Cruz et al. Pediatr Emerg Care 2012;28:889 Key Innovations in Sepsis Sepsis recognition is inconsistent at best Early Recognition = Early Treatment = Better Outcomes Sepsis is a syndrome, not a disease Minimize heterogeneity via better definition of target populations and severity Sepsis management is highly variable Minimize variation via explicit control of co-interventions Innovations in Definition LPS changed gene expression of 3,714 unique genes! Calvano et al. Nature 2005; 437:1032 Key Innovations in Sepsis Sepsis recognition is inconsistent at best Early Recognition = Early Treatment = Better Outcomes Sepsis is a syndrome, not a disease Minimize heterogeneity via better definition of target populations and severity Sepsis management is highly variable Minimize variation via explicit control of co-interventions Too Much Variation in Treatment! Minimize variation Prospective registry 276 ICU’s in 37 countries N=12,881 pts Infection 2009; 37:222 Too Much Variation in Treatment! Minimize variation Retrospective analysis N=51 critically ill children with septic shock Significant variation in duration of treatment, use of weaning taper, duration of taper Open Crit Care Med 2010; 3:51 Practice variation at CCHMC (informal chart audit): 1. 2. 3. 4. 5. 6. Choice, timing, and duration of antibiotic therapy Choice and indication for vasoactive infusions Choice and indication of mechanical ventilatory support Route and threshold for nutritional support Choice of sedative and level of sedation required Threshold for Renal Replacement Therapy (RRT) Innovations in Study Design Key Innovations in Sepsis Sepsis recognition is inconsistent at best Early Recognition = Early Treatment = Better Outcomes Sepsis is a syndrome, not a disease Minimize heterogeneity via better definition of target populations and severity Sepsis management is highly variable Minimize variation via explicit control of co-interventions Thank You! Division of Critical Care Medicine Hector R. Wong, MD Carley Riley, MD Erika Stalets, MD The James M. Anderson Center for Health Systems Excellence Stephen Muething, MD Patrick Brady, MD Uma Kotagal, MBBS, MSc Janet Jacob, RN, MBA Cincinnati Children’s Center for Simulation and Research Gary Geis, MD John Whitt, MD Tom LeMaster, RN, MSN, MEd, REMT-P, EMSI University of Cincinnati College of Medicine Amy Bunger, PhD Children’s Hospital of Akron Mary D. Patterson, MD, MEd University of Michigan Ross School of Business Kathleen M. Sutcliffe, MSN, PhD R18 HS020455 Applied Decision Science, LLC Laura Militello, MA MacroCognition, LLC Gary Klein, PhD [email protected]