Clinical trial NCT03029169: Propafenone Versus Amiodarone in Septic Shock
Official title: Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supraventricular Arrhythmia
Septic Shock
Keywords: Supraventricular Arrhythmia
Septic shock
Propafenone
Amiodarone
Intensive Care
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of propafenone
timeFrame: 1 year
measure: ICU mortality of septic shock patients on propafenone for a SV arrhythmia
timeFrame: 1 year
measure: 28-day mortality of septic shock patients on propafenone for a SV arrhythmia
timeFrame: 2 years
measure: 12-month mortality of septic shock patients on propafenone for a SV arrhythmia
timeFrame: 2 years
Secondary outcomes:
measure: Electromechanics of left atrium
timeFrame: 1 year
measure: Electromechanics of LA
timeFrame: 1 year
Other outcomes:
Locations:
city: Prague 10
country: Czechia
facility: Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University
city: Prague 2
country: Czechia
facility: Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Study officials:
affiliation: Dept of Anaesthesia and Intensive Care
name: Martin Balik, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.