EBQ:SOAP II Trial
- 1 Clinical Question
- 2 Conclusion
- 3 Major Points
- 4 Design
- 5 Population Studied
- 6 Interventions
- 7 Outcomes
- 8 Current Sepsis Guidelines
- 9 Funding
- 10 CME
- 11 Further Reading
Does dopamine decrease mortality when compared to norepinepherine as a vasopressor when treating shock?
The Sepsis Occurrence in Acutely Ill Patients (SOAP) II trial was a multi-center trial that randomized patients to receive either norepinephrine or dopamine in the treatment of shock. 
The Sepsis Occurrence in Acutely Ill Patients (SOAP) II trial randomized 1,679 patients with mostly septic shock to norepinephrine or dopamine. At 28 days, there was no difference in all-cause mortality though there was a significantly higher rate of arrhythmias in the dopamine group (24.1% vs. 12.4%; P<0.001). Currently the surviving sepsis campaign recommends norepinephrine as the first line vasopressor therapy.
- Multicenter, double-blinded, parallel-group, randomized controlled trial
- Dopamine (n=858)
- Norepinephrine (n=821)
- Setting: 8 centers in Belgium, Austria, and Spain
- Enrollment: December 2003 to October 2007
- Analysis: Intention-to-treat
- Follow-up: 28 days
- Primary outcome: All-cause mortality
- Age ≥18 years
- Shock requiring a vasopressor agent
- Shock defined as MAP <70 mmHg or systolic BP <100 despite adequate fluids (1L crystalloid or 500cc colloids)
- Unless CVP >12 or PCWP >14
- Signs of tissue hypoperfusion
- Receipt of vasopressor agent >4 hours prior to enrollment
- Serious arrhythmia (rapid atrial fibrillation >160 bpm, VT)
- Brain death
Comparisons are dopamine vs. norepinephrine.
- Septic shock 62%
- Cardiogenic shock 17%
- Hypovolemic shock 16%
- Hydrocortisone administered: 40.1% vs. 39.7%
- Activated protein C administered: 18.8% vs. 19.1%
- Patients randomized to dopamine or norepinephrine
- Doses adjusted to target BP decided by treating physician
- Dopamine max 20 mcg/kg/min
- Norepinephrine max 0.19 mcg/kg/min
- If max doses reached, open-label norepinephrine was added
- Open-label dopamine not allowed
- Epinephrine and vasopressin only as rescue agents
- Inotropes allowed as needed for cardiac output
- If adverse events occurred, treating physician could withdraw patient and change to open-label vasopressor
Comparisons are dopamine vs. norepinephrine.
- All-cause mortality at 28 days
- 52.5% vs. 48.5% (OR 1.17; 95% CI 0.97-1.42; P=0.10)
- ICU death
- 50.2% vs. 45.9% (OR 1.19; 95% CI 0.98-1.44; P=0.07)
- Inpatient mortality
- 59.4% vs. 56.6% (OR 1.12; 95% CI 0.92-1.37; P=0.24)
- 6-month mortality
- 63.8% vs. 62.9% (OR 1.06; 95% CI 0.86-1.31; P=0.71)
- 12-month mortality
- 65.9% vs. 64.0% (OR 1.15; 95% 0.91-1.46; P=0.34)
- 28-day mortality among patients with cardiogenic shock
- Increased in dopamine group compared with norepinephrine (P=0.03)
- Mortality among those with septic and hypovolemic shock
- No significant difference
- 24.1% vs. 12.4% (P<0.001)
Current Sepsis Guidelines
Surviving Sepsis Campaign (2012)
- Vasopressor therapy initially to target a mean arterial pressure (MAP) of 65 mm Hg (grade 1C).
- Norepinephrine as the first choice vasopressor (grade 1B).
- Epinephrine (added to and potentially substituted for norepinephrine) when an additional agent is needed to maintain adequate blood pressure (grade 2B).
- Vasopressin 0.03 units/minute can be added to norepinephrine (NE) with intent of either raising MAP or decreasing NE dosage (ungraded).
- Low dose vasopressin is not recommended as the single initial vasopressor for treatment of sepsis-induced hypotension and vasopressin doses higher than 0.03-0.04 units/minute should be reserved for salvage therapy (failure to achieve adequate MAP with other vasopressor agents) (ungraded).
- Dopamine as an alternative vasopressor agent to norepinephrine only in highly selected patients (eg, patients with low risk of tachyarrhythmias and absolute or relative bradycardia) (grade 2C).
- Phenylephrine is not recommended in the treatment of septic shock except in circumstances where (a) norepinephrine is associated with serious arrhythmias, (b) cardiac output is known to be high and blood pressure persistently low or (c) as salvage therapy when combined inotrope/vasopressor drugs and low dose vasopressin have failed to achieve MAP target (grade 1C).
- Low-dose dopamine should not be used for renal protection (grade 1A).
- All patients requiring vasopressors have an arterial catheter placed as soon as practical if resources are available (ungraded).
Funding provided by the European Critical Care Research Network.
- De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. The New England Journal of Medicine. 2010;362(9):779–789. doi:10.1056/NEJMoa0907118.and a subsequent meta-analysis
- Dellinter, RP et al. "Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2012." Critical Care Medicine. 2013;41(20):580-637.