title: Double-Blind Prospective Randomized Controlled Trial of Dopamine Versus Epinephrine as First-Line Vasoactive Drugs in Pediatric Septic Shock.
abstract: OBJECTIVE
  The primary outcome was to compare the effects of dopamine or epinephrine in severe sepsis on 28-day mortality; secondary outcomes were the rate of healthcare-associated infection, the need for other vasoactive drugs, and the multiple organ dysfunction score.
  
  
  METHODS
  Double-blind, prospective, randomized controlled trial from February 1, 2009, to July 31, 2013.
  
  
  METHODS
  PICU, Hospital Universitário da Universidade de São Paulo, Brazil.
  
  
  METHODS
  Consecutive children who are 1 month to 15 years old and met the clinical criteria for fluid-refractory septic shock. Exclusions were receiving vasoactive drug(s) prior to hospital admission, having known cardiac disease, having already participated in the trial during the same hospital stay, refusing to participate, or having do-not-resuscitate orders.
  
  
  METHODS
  Patients were randomly assigned to receive either dopamine (5-10 μg/kg/min) or epinephrine (0.1-0.3 μg/kg/min) through a peripheral or intraosseous line. Patients not reaching predefined stabilization criteria after the maximum dose were classified as treatment failure, at which point the attending physician gradually stopped the study drug and started another catecholamine.
  
  
  RESULTS
  Physiologic and laboratory data were recorded. Baseline characteristics were described as proportions and mean (± SD) and compared using appropriate statistical tests. Multiple regression analysis was performed, and statistical significance was defined as a p value of less than 0.05. Baseline characteristics and therapeutic interventions for the 120 children enrolled (63, dopamine; 57, epinephrine) were similar. There were 17 deaths (14.2%): 13 (20.6%) in the dopamine group and four (7%) in the epinephrine group (p=0.033). Dopamine was associated with death (odds ratio, 6.5; 95% CI, 1.1-37.8; p=0.037) and healthcare-associated infection (odds ratio, 67.7; 95% CI, 5.0-910.8; p=0.001). The use of epinephrine was associated with a survival odds ratio of 6.49.
  
  
  CONCLUSIONS
  Dopamine was associated with an increased risk of death and healthcare-associated infection. Early administration of peripheral or intraosseous epinephrine was associated with increased survival in this population. Limitations should be observed while interpreting these results.
authors: 1Department of Pediatrics, Pediatric Intensive Care Unit, Hospital Universitário da Universidade de São Paulo, São Paulo, Brazil. 2Department of Pediatrics, Pediatric Emergency Department, Hospital Universitário da Universidade de São Paulo, São Paulo, Brazil.
authors: Andréa M C
authors: AM
authors: Ventura
authors: Huei Hsin
authors: HH
authors: Shieh
authors: Albert
authors: A
authors: Bousso
authors: Patrícia F
authors: PF
authors: Góes
authors: Iracema
authors: I
authors: de Cássia F O Fernandes
authors: Daniela C
authors: DC
authors: de Souza
authors: Rodrigo Locatelli Pedro
authors: RL
authors: Paulo
authors: Fabiana
authors: F
authors: Chagas
authors: Alfredo E
authors: AE
authors: Gilio
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D016638:Critical Illness / Q000628:therapy; D004298:Dopamine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004837:Epinephrine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends*; D006785:Hospitals, University; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay; D016014:Linear Models; D008297:Male; D015999:Multivariate Analysis; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D012772:Shock, Septic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014662:Vasoconstrictor Agents; D004298:Dopamine; D004837:Epinephrine