Propafenone Versus Amiodarone in Septic Shock

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 4, 2022

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.

Interventions

  • Drug: Propafenone i.v.
    • Treatment
  • Drug: Amiodarone i.v.
    • Treatment

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of propafenone
    • Time Frame: 1 year
    • cardioversion rate
  • ICU mortality of septic shock patients on propafenone for a SV arrhythmia
    • Time Frame: 1 year
    • ICU mortality
  • 28-day mortality of septic shock patients on propafenone for a SV arrhythmia
    • Time Frame: 2 years
    • 28-day mortality
  • 12-month mortality of septic shock patients on propafenone for a SV arrhythmia
    • Time Frame: 2 years
    • 12-month mortality

Secondary Measures

  • Electromechanics of left atrium
    • Time Frame: 1 year
    • left atrial emptying
  • Electromechanics of LA
    • Time Frame: 1 year
    • isovolumic and ejection times

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charles University, Czech Republic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin Balik, A/Prof, MD, PhD – Charles University, Czech Republic
  • Overall Official(s)
    • Martin Balik, A/Prof, Principal Investigator, Dept of Anaesthesia and Intensive Care

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