PRASE
Trial question
What is the role of propafenone in patients with septic shock who had new-onset arrhythmia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 209
209 patients (80 female, 129 male).
Inclusion criteria: patients with septic shock who had new-onset arrhythmia and a LVEF > 35%.
Key exclusion criteria: severe LV systolic dysfunction; history indicating an AV block > 1st degree; high dose vasopressor therapy represented by noradrenaline > 1.0 mcg/kg/min; dependence on a pacemaker or status after Maze procedure.
Interventions
N=104 propafenone (70 mg bolus followed by continuous infusion of 400-840 mg/24 hour).
N=105 amiodarone (300 mg bolus followed by continuous infusion of 600-1,800 mg/24 hours).
Primary outcome
Proportion of patients with sinus rhythm 24 hours after start of infusion
72.8%
67.3%
72.8 %
54.6 %
36.4 %
18.2 %
0.0 %
Propafenone
Amiodarone
No significant
difference ↔
No significant difference in the proportion of patients with sinus rhythm 24 hours after the start of infusion (72.8% vs. 67.3%; RR 1.08, 95% CI -1.4 to 3.56).
Secondary outcomes
Significantly shorter median time to cardioversion (3.7 hours vs. 7.3 hours; AD -3.6 hours, 95% CI -6.68 to -0.52).
Significant decrease in arrhythmia recurrence (52% vs. 76%; RR 0.68, 95% CI 0.28 to 1.08).
No significant difference in death in the ICU (36.5% vs. 41%; RR 0.89, 95% CI -0.04 to 1.82).
Conclusion
In patients with septic shock who had new-onset arrhythmia and a LVEF > 35%, propafenone was not superior to amiodarone with respect to proportion of patients with sinus rhythm 24 hours after the start of infusion.
Reference
Martin Balik, Michal Maly, Tomas Brozek et al. Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial. Intensive Care Med. 2023 Nov;49(11):1283-1292.
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