Propafenone Versus Amiodarone in Septic Shock

Phase 4

Completed

• Conditions: Supraventricular Arrhythmia; Septic Shock
• Interventions: Drug: Propafenone i.v.; Drug: Amiodarone i.v.

• Registration Number: NCT03029169
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Study Start: 2017-10-23
• Primary Completion: 2022-07-04
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propafenone i.v.	Propafenone i.v.	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.
Amiodarone i.v.	Amiodarone i.v.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Electromechanics of left atrium	1 year	left atrial emptying
Electromechanics of LA	1 year	isovolumic and ejection times

Trial Locations

Locations (2)

Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University; 🇨🇿 Prague 2, Czechia

Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University; 🇨🇿 Prague 10, Czechia