Propafenone Versus Amiodarone in Septic Shock

Conditions

Septic Shock, Supraventricular Arrhythmia

Keywords

Supraventricular Arrhythmia, Septic shock, Propafenone, Amiodarone, Intensive Care

Brief summary

Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.

Detailed description

Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. Secondary aims are to monitor the electromechanics of left atrium in patients with SV arrhythmias in septic shock.

M. Balik, T. Tencer, E. Svobodova, M. Otáhal, I. Jurisinova et al. (9 authors)

Frontiers in Cardiovascular Medicine2026-05-07

10.3389/fcvm.2026.1807380

Echocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock

Martin Balík, Petr Waldauf, Michal Malý, Tomáš Brožek, Jan Rulíšek et al. (23 authors)

Journal of Critical Care2024-05-163 citations

10.1016/j.jcrc.2024.154832

The outcomes of patients with septic shock treated with propafenone compared to amiodarone for supraventricular arrhythmias are related to end-systolic left atrial volume

Petr Waldauf, Michal Pořízka, Jan Horejsek, Michal Otáhal, Eliška Svobodová et al. (14 authors)

European Heart Journal Acute Cardiovascular Care2024-02-198 citations

10.1093/ehjacc/zuae023

Efficacy and safety of 1C class antiarrhythmic agent (propafenone) for supraventricular arrhythmias in septic shock compared to amiodarone: protocol of a prospective randomised double-blind study

Martin Balík, Petr Waldauf, Michal Malý, Vojtěch Matoušek, Tomáš Brožek et al. (17 authors)

BMJ Open2019-09-0110 citations

10.1136/bmjopen-2019-031678

Interventions

DRUGPropafenone i.v.

Treatment

DRUGAmiodarone i.v.

Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Provided by a dedicated study nurse

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

No

Inclusion criteria

* Septic shock with a new onset SV arrhythmia * LV systolic function normal to moderately reduced according to echocardiography.

Exclusion criteria

* Severe LV systolic dysfunction * More than 1st degree AV block * High dose vasopressor therapy with continuous noradrenaline \> 1.0 ug/kg.min * Known intolerance to amiodarone or propafenone * Absence of septic shock * Chronic AF * Dependence on pacemaker * Status after MAZE procedure

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of propafenone	1 year	cardioversion rate
ICU mortality of septic shock patients on propafenone for a SV arrhythmia	1 year	ICU mortality
28-day mortality of septic shock patients on propafenone for a SV arrhythmia	2 years	28-day mortality
12-month mortality of septic shock patients on propafenone for a SV arrhythmia	2 years	12-month mortality

Secondary

Measure	Time frame	Description
Electromechanics of left atrium	1 year	left atrial emptying
Electromechanics of LA	1 year	isovolumic and ejection times

Countries

Czechia

Outcome results

None listed