We evaluated a strategy of dopamine (DA) vs norepinephrine (NE) as the primary vasopressor support in patients with septic shock. Concern for potential adverse events or a significant improvement in outcome prompted an interim safety analysis after approximately 50% of the target subjects were enrolled.
MICU patients with septic shock were prospectively randomized to receive either DA or NE as the first-line vasopressor. All patients were treated with early-goal directed medical therapy including luid resuscitation, antibiotics, tight glycemic control and management of adrenal insufficiency, as appropriate. A protocol governed the titration of vasopressors to achieve a mean arterial pressure (MAP) of > 60mmHg or systolic blood pressure (SBP) > 90mmHg. After the maximum dose of either DA or NE was reached, patients received vasopressin at a fixed dose of 0.04 units/minute, followed by titration of phenylephrine to maintain the blood pressure goal. An interim analysis was performed to evaluate safety and efficacy of each vasopressor.
Sixty-six patients, 35 DA and 31 NE, have been enrolled in the study. APACHE II scores, gender, and age were all similar at baseline between the two groups. There was no significant difference in mortality comparing the two groups (DA 40%, NE 41.8%). Cardiac dysrhythmias occurred in 31.4% of the DA group compared to 3.2% for NE (p=0.003). All cardiac dysrhythmias required an intervention.
There was a significant increase in cardiac dysrhythmias associated with DA treatment in comparison to NE treatment of septic shock.
While there was no significant difference in mortality between the two vasopressor regimens, the significant increase in dysrhythmias associated with DA administration raises significant safety concerns. Further testing is needed to confirm the safety of dopamine and ensure that it is not detrimental to septic shock patients.
Jaime Simon Grahe, None.