title: Study protocol for a Multi-centre, Investigator-initiated, Randomized Controlled Trial to Compare the Effects of Prehospital Antibiotic Treatment for Sepsis Patients with Usual Care after Training Emergency Medical Services (EMS) Personnel in Early Recognition (- The Prehospital ANTibiotics Against Sepsis (PHANTASi) trial.
abstract: 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.
authors.affiliation: Section acute medicine, Department of Internal Medicine and Institute of Cardiovascular research, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Nadia
authors.initials: N
authors.lastname: Alam
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Amsterdam, The Netherlands.
authors.forename: Peter M van
authors.initials: PM
authors.lastname: de Ven
authors.affiliation: Department of Emergency Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
authors.forename: Erick
authors.initials: E
authors.lastname: Oskam
authors.affiliation: Section acute medicine, Division of General Medicine, Department of Internal Medicine, School of Caphri, Maastricht University Medical Centre, The Netherlands.
authors.forename: Patricia
authors.initials: P
authors.lastname: Stassen
authors.affiliation: Section acute medicine, Department of Internal Medicine and Institute of Cardiovascular research, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Mark Hh
authors.initials: MH
authors.lastname: Kramer
authors.affiliation: Ambulance Amsterdam, The Netherlands.
authors.forename: Pieternel van
authors.initials: PV
authors.lastname: Exter
authors.affiliation: Section acute medicine, Department of Internal Medicine and Institute of Cardiovascular research, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Prabath Wb
authors.initials: PW
authors.lastname: Nanayakkara
mesh_terms: D000328:Adult; D000368:Aged; D042241:Early Diagnosis; D004632:Emergency Medical Services / Q000458:organization & administration*; D004634:Emergency Medical Technicians / Q000193:education*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D015588:Observer Variation; D011379:Prognosis; D018570:Risk Assessment; D018805:Sepsis / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D016896:Treatment Outcome