Double-Blind Randomized Clinical Trial Comparing Dopamine and Epinephrine in Pediatric Fluid-Refractory Hypotensive Septic Shock

Pediatr Crit Care Med. 2016 Nov;17(11):e502-e512. doi: 10.1097/PCC.0000000000000954.

Abstract

Objective: We compared efficacy of dopamine and epinephrine as first-line vasoactive therapy in achieving resolution of shock in fluid-refractory hypotensive cold septic shock.

Design: Double-blind, pilot, randomized controlled study.

Setting: Pediatric emergency and ICU of a tertiary care teaching hospital.

Patients: Consecutive children 3 months to 12 years old, with fluid-refractory hypotensive septic shock, were enrolled between July 2013 and December 2014.

Intervention: Enrolled children were randomized to receive either dopamine (in incremental doses, 10 to 15 to 20 μg/kg/min) or epinephrine (0.1 to 0.2 to 0.3 μg/kg/min) till end points of resolution of shock were achieved. After reaching maximum doses of test drugs, open-label vasoactive was started as per discretion of treating team. Primary outcome was resolution of shock within first hour of resuscitation. The study was registered (CTRI/2014/02/004393) and was approved by institute ethics committee.

Measurements and main results: We enrolled 29 children in epinephrine group and 31 in dopamine group. Resolution of shock within first hour was achieved in greater proportion of children receiving epinephrine (n = 12; 41%) than dopamine (n = 4; 13%) (odds ratio, 4.8; 95% CI, 1.3-17.2; p = 0.019); the trend persisted even at 6 hours (48.3% vs 29%; p = 0.184). Children in epinephrine group had lower Sequential Organ Function Assessment score on day 3 (8 vs 12; p = 0.05) and more organ failure-free days (24 vs 20 d; p = 0.022). No significant difference in adverse events (16.1% vs 13.8%; p = 0.80) and mortality (58.1% vs 48.3%; p = 0.605) was observed between the two groups.

Conclusion: Epinephrine is more effective than dopamine in achieving resolution of fluid-refractory hypotensive cold shock within the first hour of resuscitation and improving organ functions.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child, Preschool
  • Dopamine / therapeutic use*
  • Dopamine Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Epinephrine / therapeutic use*
  • Female
  • Fluid Therapy
  • Follow-Up Studies
  • Humans
  • Infant
  • Infusions, Intravenous
  • Intention to Treat Analysis
  • Male
  • Pilot Projects
  • Shock, Septic / drug therapy*
  • Shock, Septic / therapy
  • Treatment Outcome
  • Vasoconstrictor Agents / therapeutic use*

Substances

  • Dopamine Agents
  • Vasoconstrictor Agents
  • Dopamine
  • Epinephrine

Associated data

  • CTRI/CTRI/2014/02/004393