NCT03029169|CompletedPhase 4DMC
Propafenone Versus Amiodarone in Septic Shock
PRASE
Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
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Sponsor study identifier
interventional
210
1 country
2
Study Start
October 23, 2017
Actual (reported)Primary Completion
July 4, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 7, 2016
Actual (reported)January 24, 2017
Actual (reported)October 23, 2017
Actual (reported)July 4, 2022
Actual (reported)August 1, 2022
Actual (reported)Efficacy of propafenone
cardioversion rate
1 year
ICU mortality of septic shock patients on propafenone for a SV arrhythmia
ICU mortality
1 year
28-day mortality of septic shock patients on propafenone for a SV arrhythmia
28-day mortality
2 years
12-month mortality of septic shock patients on propafenone for a SV arrhythmia
12-month mortality
2 years
Electromechanics of left atrium
1 year
Electromechanics of LA
1 year
Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment. Intervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h.
Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment. Intervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h.
Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University
Prague, 100 34, Czechia
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 128 08, Czechia
Balik M, Tencer T, Svobodova E, Otahal M, Jurisinova I, Kaspar V, Krajcova A, Duska F, Waldauf P. Propafenone is associated with fewer recurrences of supraventricular arrhythmias in mechanically ventilated patients with septic shock and right ventricular dysfunction. Front Cardiovasc Med. 2026 May 7;13:1807380. doi: 10.3389/fcvm.2026.1807380. eCollection 2026.
Balik M, Waldauf P, Maly M, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Horejsek J, Volny L, Jurisinova I, Novotny A, Trachta P, Kunstyr J, Kopecky P, Tencer T, Pazout J, Krajcova A, Duska F. Echocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock. J Crit Care. 2024 Oct;83:154832. doi: 10.1016/j.jcrc.2024.154832. Epub 2024 May 17.
Martin Balik, A/Prof
Dept of Anaesthesia and Intensive Care
210 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2016
First Posted
January 24, 2017
Study Start
October 23, 2017
Actual (reported)Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock Trial. VIPER-Sepsis (EudraCT no. 2016-000707-81)
Contact the study team to confirm eligibility.
Waldauf P, Porizka M, Horejsek J, Otahal M, Svobodova E, Jurisinova I, Maly M, Brozek T, Rulisek J, Trachta P, Tencer T, Krajcova A, Duska F, Balik M. The outcomes of patients with septic shock treated with propafenone compared to amiodarone for supraventricular arrhythmias are related to end-systolic left atrial volume. Eur Heart J Acute Cardiovasc Care. 2024 May 28;13(5):414-422. doi: 10.1093/ehjacc/zuae023.
Balik M, Waldauf P, Maly M, Matousek V, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Pazout J, Duska F, Smid O, Stritesky M. 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. BMJ Open. 2019 Sep 3;9(9):e031678. doi: 10.1136/bmjopen-2019-031678.
Primary Completion
July 4, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)Last Updated
August 2, 2022
Record last verified: 2022-08
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