SOAP-II Trial

NEJM

March 4, 2010

Comparison of Dopamine and Norepinephrine in the Treatment of Shock.

Summarized by: 

Mazen Kherallah

What was the research question?

  • In patients with shock, does the use of dopamine improve 28-day mortality compared to norepinephrine?


How did they do it?

  • A multicenter, randomized trial in eight centers in Belgium, Austria, and Spain.

  • 1679 patients with shock were randomized to receive either dopamine (858 patients) or norepinephrine (821 patients) as first-line vasopressor therapy to maintain a mean arterial pressure of 65 mm Hg. Open label vasopressors (norepinephrine, epinephrine, or vasopressin) could be added if the target was not achieved or maintained with 20 μg/kg/min of dopamine or 0.19 μg/kg/min of norepinephrine.

  • The primary outcome was 28-day mortality, and the secondary outcomes included the number of days without need for organ support and the occurrence of adverse events.


What did they find?

  • 28-day mortality was not significantly different between the dopamine group and the norepinephrine group (52.5% vs. 48.5%, P=0.10).

  • There were more arrhythmic events (mostly atrial fibrillation) among the patients treated with dopamine compared to those treated with norepinephrine (24.1% vs. 12.4%, P<0.001).

  • Vasopressors free days were significantly worse for dopamine group compared to norepinephrine group (10 days vs. 12.5 days, P=0.01). No difference in ventilator-free days or renal failure-free days.

  • A subgroup analysis in predefined subgroups showed that patients with cardiogenic shock had significantly a higher 28-day mortality with dopamine compared to norepinephrine (p=0.03), but not with patients who had septic (P=0.19) or hypovolemic shock (P-0.84).

  • ICU, hospital, 6-month and 12-month mortality rates were not different between the groups.

  • Patients in the dopamine group required more open-label norepinephrine (26% vs. 20%, P<0.001), indicating that norepinephrine was more effective in achieving the goals.


What does it mean?

  • The rate of death was not different in patients treated with dopamine compared to norepinephrine. However, dopamine caused more arrhythmias in all groups and was associated with a higher rate of death in cardiogenic shock patients.

  • Use norepinephrine as a first-line agent in all types of shocks.

SOAP-II Trial