Epinephrine versus dopamine in neonatal septic shock: a double-blind randomized controlled trial

We compared epinephrine and dopamine as a first-line vasoactive drug in 40 neonates (enrolled in two gestational age strata ≤ 30^6/7 and ≥ 31^0/7 weeks) with fluid-refractory septic shock. Epinephrine or dopamine was initiated at 0.2 or 10 μg/kg/min, respectively. If shock persisted after 15 min, epinephrine or dopamine was increased to 0.3 or 15 μg/kg/min, respectively (16-30 min), and thereafter to 0.4 or 20 μg/kg/min (31-45 min). Proportion of neonates achieving 'reversal of shock' (defined as systolic and diastolic BP > fifth centile and capillary filling time < 3 s and left ventricular output ≥ 150 mL/kg/min) by 45 min [5 (25%) vs 6 (30%), RR 0.83 (95% CI 0.30, 2.29)]; haemodynamic stability (shock reversal for ≥ 120 min without escalation of vasoactive drugs) anytime during therapy [10 (50%) vs 6 (30%), RR 1.67 (95% CI 0.75, 3.71)]; and all-cause mortality by 28 days [14 (70%) vs 16 (80%), RR 0.87 (95% CI 0.61, 1.26)] were comparable in the epinephrine and dopamine groups, respectively. On stratified analysis, we observed an interaction of gestational age strata with the group of allocation favouring epinephrine in neonates ≤ 30^6/7 weeks.Conclusion: Epinephrine (0.2-0.4 μg/kg/min) and dopamine (10-20 μg/kg/min) had comparable efficacy and safety in neonatal septic shock.Clinical Trial registry name and registration number: The study was registered with Clinical Trial Registry of India CTRI/2015/10/006285. What is Known: • The choice of vasoactive drugs in neonatal septic shock is empirical and dopamine is the conventional first-line vasoactive drug. • There are no randomized controlled trials comparing dopamine and epinephrine in neonatal septic shock. What is New: • In this study, epinephrine and dopamine had comparable efficacy and safety as a first-line vasoactive drug in management of neonatal septic shock. • On stratified analysis in a limited sample, epinephrine was associated with better outcomes in neonates ≤ 30^6/7 weeks.