title: Emergency Department Management of Sepsis Patients: A Randomized, Goal-Oriented, Noninvasive Sepsis Trial.
abstract: OBJECTIVE
  The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically ill patients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the emergency department.
  
  
  METHODS
  In this open-label randomized controlled trial, 122 adult patients with sepsis and serum lactate concentration of greater than or equal to 3.0 mmol/L were randomized to receive usual care or intravenous fluid bolus administration guided by measurements of change of stroke volume index, using the noninvasive cardiac output monitor after passive leg-raising maneuver. The primary outcome was lactate clearance of more than 20% at 3 hours. Secondary outcomes included mortality, length of hospital and ICU stay, and total hospital cost. Analysis was intention to treat.
  
  
  RESULTS
  Similar proportions of patients in the randomized intervention group (70.5%; N=61) versus control group (73.8%; N=61) achieved the primary outcome, with a relative risk of 0.96 (95% confidence interval [CI] 0.77 to 1.19). Secondary outcomes were similar in both groups (P>.05 for all comparisons). Hospital mortality occurred in 6 patients (9.8%) each in the intervention and control groups on or before 28 days (relative risk=1.00; 95% CI 0.34 to 2.93). Among a subgroup of patients with underlying fluid overload states, those in the intervention group tended to receive clinically significantly more intravenous fluids at 3 hours (difference=975 mL; 95% CI -450 to 1,725 mL) and attained better lactate clearance (difference=19.7%; 95% CI -34.6% to 60.2%) compared with the control group, with shorter hospital lengths of stay (difference=-4.5 days; 95% CI -9.5 to 2.5 days).
  
  
  CONCLUSIONS
  Protocol-based fluid resuscitation of patients with severe sepsis and septic shock with the noninvasive cardiac output monitor and passive leg-raising maneuver did not result in better outcomes compared with usual care. Future studies to demonstrate the use of the noninvasive protocol-based care in patients with preexisting fluid overload states may be warranted.
authors.affiliation: Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore. Electronic address: win_sen_kuan@nuhs.edu.sg.
authors.forename: Win Sen
authors.initials: WS
authors.lastname: Kuan
authors.affiliation: Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
authors.forename: Irwani
authors.initials: I
authors.lastname: Ibrahim
authors.affiliation: Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
authors.forename: Benjamin S H
authors.initials: BS
authors.lastname: Leong
authors.affiliation: Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore.
authors.forename: Swati
authors.initials: S
authors.lastname: Jain
authors.affiliation: Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore; Singapore Clinical Research Institute, Singapore.
authors.forename: Qingshu
authors.initials: Q
authors.lastname: Lu
authors.affiliation: Centre for Quantitative Medicine, Duke-NUS Graduate Medicine School, Singapore; Department of International Health, University of Tampere, Tampere, Finland.
authors.forename: Yin Bun
authors.initials: YB
authors.lastname: Cheung
authors.affiliation: Emergency Medicine Department, National University Hospital, National University Health System, Singapore and the Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Mahadevan
mesh_terms: D000368:Aged; D003422:Critical Care / Q000458:organization & administration*; D019468:Disease Management; D004636:Emergency Service, Hospital / Q000458:organization & administration*; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D017721:Hospital Costs; D017052:Hospital Mortality; D006801:Humans; D007773:Lactates / Q000097:blood; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation; D009937:Organizational Objectives; D018805:Sepsis / Q000097:blood / Q000401:mortality / Q000628:therapy*; D012772:Shock, Septic / Q000097:blood / Q000401:mortality / Q000628:therapy; D012846:Singapore / Q000453:epidemiology; D013318:Stroke Volume; D016896:Treatment Outcome
chemical_list: D007773:Lactates