Propafenone Versus Amiodarone in Septic Shock (PRASE)

Charles University, Czech Republic

Status and phase: Completed; Phase 4

Conditions: Supraventricular Arrhythmia; Septic Shock

Treatments: Drug: Amiodarone i.v.; Drug: Propafenone i.v.

Study type: Interventional

Funder types: Other

Identifiers

NCT03029169

1691/16 S-IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Propafenone i.v.

Active Comparator group

Description:

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.

Treatment:

Drug: Propafenone i.v.

Amiodarone i.v.

Active Comparator group

Description:

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.

Treatment:

Drug: Amiodarone i.v.