Abstract
Introduction: Sepsis is one of the most frequent reasons for referral to emergency departments (EDs) worldwide. Sepsis becomes more serious when left untreated with a high mortality rate, exceeding even those of myocardial infarction and stroke. Therefore, much effort has been put in to start with appropriate therapy as early as possible. Emergency medical services (EMS) personnel have already made a significant difference in improving care for patients with acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic shock could also benefit from timely prehospital care. Earlier recognition and initiation of treatment by EMS personnel may improve survival of these critically ill patients.
Methods and analysis: The Prehospital Antibiotics against Sepsis (PHANTASi) trial is an investigator- initiated, multicentre, randomized controlled open-label clinical trial nested within a step wedge design. This study compares the effects of usual care to that of training EMS personnel in recognizing and initiating treatment in the prehospital setting together with early administration of antibiotics for patients suspected of (severe) sepsis and septic shock. Primary outcome is 28 day mortality. Secondary outcomes include, length of hospital stay and admission to intensive care units.
Ethics and dissemination: This study has been approved by the research ethics committee of VU University Medical Centre, Amsterdam, The Netherlands (Protocol 2013.458/ NL 42001.029.13). The results of the study will be disseminated at several research conferences and international peer reviewed journals. The study will be implemented and reported in line with the CONSORT statement.
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References
- Jawad I, Luksic I, Rafnsson SB. Assessing available information on the burden of sepsis: global estimates of incidence, prevalence and mortality. J Glob Health 2012 Jun;2(1):010404.
- Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001 Jul;29(7):1303-10.
- Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med 2003 Apr 17;348(16):1546-54.
- Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med 2008 Jan;34(1):17-60.
- Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006 Jun;34(6):1589-96.
- Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, et al. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med 2014 Aug;42(8):1749-55.
- Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med 2004 Mar 22;164(6):637-44.
- Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, et al. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med 2010 Apr;38(4):1045-53.
- Roedig A (RIVM). Ziekenhuisopnamen sepsis en pyemie 2001-In: Volksgezondheid Toekomst Verkenning, Nationaal Kompas Volksgezondheid. Bilthoven: RIVM. 2015. Ref Type: Generic
- Bakker J, Levi M, van Hout BA, van GA. [Sepsis, a complicated syndrome with major medical and social consequences]. Ned Tijdschr Geneeskd 2004 May 15;148(20):975-8.
- de Miguel-Yanes JM, Andueza-Lillo JA, Gonzalez-Ramallo VJ, Pastor L, Munoz J. Failure to implement evidence-based clinical guidelines for sepsis at the ED. Am J Emerg Med 2006 Sep;24(5):553-9.
- Sebat F, Musthafa AA, Johnson D, Kramer AA, Shoffner D, Eliason M, et al. Effect of a rapid response system for patients in shock on time to treatment and mortality during 5 years. Crit Care Med 2007 Nov;35(11):2568-75.
- O’Neill R, Morales J, Jule M. Early goal-directed therapy (EGDT) for severe sepsis/septic shock: which components of treatment are more difficult to implement in a community-based emergency department? J Emerg Med 2012 May;42(5):503-10.
- Ghosh R, Pepe P. The critical care cascade: a systems approach. Curr Opin Crit Care 2009 Aug;15(4):279-83.
- Robson W, Nutbeam T, Daniels R. Sepsis: a need for prehospital intervention? Emerg Med J 2009 Jul;26(7):535-8.
- Seymour CW, Kahn JM, Cooke CR, Watkins TR, Heckbert SR, Rea TD. Prediction of critical illness during out-of-hospital emergency care. JAMA 2010 Aug 18;304(7):747-54.
- Band RA, Gaieski DF, Hylton JH, Shofer FS, Goyal M, Meisel ZF. Arriving by emergency medical services improves time to treatment endpoints for patients with severe sepsis or septic shock. Acad Emerg Med 2011 Sep;18(9):934-40.
- Studnek JR, Artho MR, Garner CL, Jr., Jones AE. The impact of emergency medical services on the ED care of severe sepsis. Am J Emerg Med 2012 Jan;30(1):51-6.
- Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet 1974 Jul 13;2(7872):81-4.
- Royal College of Physicians. National Early Warning Score (NEWS): Standardising the assessment of acute illness severity in the NHS. Report of a working party. 2012, London RCP Ref Type: Generic
- Horeczko T, Green JP, Panacek EA. Epidemiology of the Systemic Inflammatory Response Syndrome (SIRS) in the emergency department. West J Emerg Med 2014 May;15(3):329-36.
- Suffoletto B, Frisch A, Prabhu A, Kristan J, Guyette FX, Callaway CW. Prediction of serious infection during prehospital emergency care. Prehosp Emerg Care 2011 Jul;15(3):325-30.
- Groenewoudt M, Roest AA, Leijten FM, Stassen PM. Septic patients arriving with emergency medical services: a seriously ill population. Eur J Emerg Med 2014 Oct;21(5):330-5.
- van der Wekken AJ, Hiltermann TJ, Groen HJ. The value of proteomics in lung cancer. Ann Transl Med 2015 Mar;3(3):29.
- Guerra WF, Mayfield TR, Meyers MS, Clouatre AE, Riccio JC. Early detection and treatment of patients with severe sepsis by prehospital personnel. J Emerg Med 2013 Jun;44(6):1116-25.
- Assuncao M, Akamine N, Cardoso GS, Mello PV, Teles JM, Nunes AL, et al. Survey on physicians’ knowledge of sepsis: do they recognize it promptly? J Crit Care 2010 Dec;25(4):545-52.
- Cronshaw HL, Daniels R, Bleetman A, Joynes E, Sheils M. Impact of the Surviving Sepsis Campaign on the recognition and management of severe sepsis in the emergency department: are we failing? Emerg Med J 2011 Aug;28(8):670-5.
- Uittenbogaard AJ, de Deckere ER, Sandel MH, Vis A, Houser CM, de GB. Impact of the diagnostic process on the accuracy of source identification and time to antibiotics in septic emergency department patients. Eur J Emerg Med 2014 Jun;21(3):212-9.
- Horeczko T, Green JP, Panacek EA. Epidemiology of the Systemic Inflammatory Response Syndrome (SIRS) in the emergency department. West J Emerg Med 2014 May;15(3):329-36.
