Propafenone Versus Amiodarone in Septic Shock

NCT03029169 | Completed Phase 4 DMC

• 1 other identifier: 1691/16 S-IV
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Supraventricular Arrhythmia; Septic Shock

Keywords

Supraventricular Arrhythmia; Septic shock; Propafenone; Amiodarone; Intensive Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Electromechanics of left atrium

  1 year

• Electromechanics of LA

  1 year

Study Arms (2)

Propafenone i.v.

ACTIVE COMPARATOR

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.

Amiodarone i.v.

ACTIVE COMPARATOR

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.

Interventions

Propafenone i.v. DRUG

Treatment

Also known as: Antiarrhythmic therapy

Propafenone i.v.

Amiodarone i.v. DRUG

Treatment

Also known as: Antiarrhythmic therapy

Amiodarone i.v.

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Septic shock with a new onset SV arrhythmia
• LV systolic function normal to moderately reduced according to echocardiography.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (2)

Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University

Prague, 100 34, Czechia

Location

Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University

Prague, 128 08, Czechia

Location

Related Publications (3)

• Balik M, Waldauf P, Maly M, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Horejsek J, Volny L, Jurisinova I, Novotny A, Trachta P, Kunstyr J, Kopecky P, Tencer T, Pazout J, Krajcova A, Duska F. Echocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock. J Crit Care. 2024 Oct;83:154832. doi: 10.1016/j.jcrc.2024.154832. Epub 2024 May 17.

  PMID: 38759581 DERIVED

• Waldauf P, Porizka M, Horejsek J, Otahal M, Svobodova E, Jurisinova I, Maly M, Brozek T, Rulisek J, Trachta P, Tencer T, Krajcova A, Duska F, Balik M. The outcomes of patients with septic shock treated with propafenone compared to amiodarone for supraventricular arrhythmias are related to end-systolic left atrial volume. Eur Heart J Acute Cardiovasc Care. 2024 May 28;13(5):414-422. doi: 10.1093/ehjacc/zuae023.

  PMID: 38372622 DERIVED

• 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.

  PMID: 31481571 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Martin Balik, A/Prof

  Dept of Anaesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Provided by a dedicated study nurse
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof, MD, PhD

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: January 24, 2017
• Study Start: October 23, 2017
• Primary Completion: July 4, 2022
• Study Completion: August 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)