Propafenone Versus Amiodarone in Septic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock

Conditions
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Supraventricular Arrhythmia, Septic Shock

Intervention / Treatment
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* Drug: Propafenone i.v.
* Drug: Amiodarone i.v.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propafenone i.v.<br>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. | Drug: Propafenone i.v.<br>* Treatment<br>* Other names: Antiarrhythmic therapy;|
| Active Comparator: Amiodarone i.v.<br>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. | Drug: Amiodarone i.v.<br>* Treatment<br>* Other names: Antiarrhythmic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromechanics of left atrium | left atrial emptying | 1 year | 
| Electromechanics of LA | isovolumic and ejection times | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraventricular Arrhythmia, Septic shock, Propafenone, Amiodarone, Intensive Care