SOAP II
Trial question
What is the role of dopamine as first-line vasopressor agent in patients with shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 1679
1679 patients (723 female, 956 male)
Inclusion criteria: patients with shock
Key exclusion criteria: age < 18 years; already received a vasopressor agent (dopamine, norepinephrine, epinephrine, or phenylephrine) for > 4 hours during the current episode of shock; serious arrhythmia, such as rapid AF (> 160 beats/min) or VT; or declared brain-dead
Interventions
N=858 dopamine (dose determined according to the patient's body weight, could be increased or decreased by 2 mcg/kg/min)
N=821 norepinephrine (dose determined according to the patient's body weight, could be increased or decreased by 0.02 mcg/kg/min)
Primary outcome
Death at 28 days
52.5
48.5
52.5 %
39.4 %
26.3 %
13.1 %
0.0 %
Dopamine
Norepinephrine
No significant
difference ↔
No significant difference in death at 28 days (52.5% vs. 48.5%; OR 1.17, 95% CI 0.97 to 1.42)
Secondary outcomes
Significant increase in required open-label norepinephrine therapy (26% vs. 20%; RR 1.3, 95% CI 0.53 to 2.07)
Significant increase in open-label vasopressors not needed (12.6 vs. 14.2 ; MD 1.6, 95% CI 0.44 to 2.76)
Safety outcomes
Significant differences in arrhythmic events (24.1% vs. 12.4%, p < 0.001).
Conclusion
In patients with shock, dopamine was not superior to norepinephrine with respect to death at 28 days.
Reference
De Backer D, Biston P, Devriendt J et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010 Mar 4;362(9):779-89.
Open reference URL