Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 4/5
De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators.
N Engl J Med. 2010 Mar 4;362(9):779-89
This pragmatic, blinded, randomized, multicenter ICU trial comparing dopamine and norepinephrine in the treatment of shock found that there was no difference in the primary outcome of death at 28 days between study groups (P=0.10), but more arrhythmic events in patients treated with dopamine (24.1% vs 12.4%; P<0.001) and an increased rate of death in patients with cardiogenic shock treated with dopamine (P=0.03). This study was considered to be a landmark trial, resulting in a change of practice towards the utilization of norepinephrine as the first line agent in the treatment of shock in a tertiary care center.
By: Dr. Timothy Dalseg
(Presented November 2013)
Epi lesson: Pragmatic vs. explanatory trials
Explanatory randomized controlled trials are those conducted under idealized conditions where inclusion and exclusion criteria are strict to create homogeneous populations and evaluate efficacy of an intervention. Pragmatic trials are more “real-life”, aim to determine effectiveness and consider outcomes which are of most interest to patients.
By: Dr. Lisa Calder