Propafenone Versus Amiodarone in Septic Shock

Septic Shock Clinical Trial

— PRASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029169
• Other study ID #: 1691/16 S-IV
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 1, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Septic Shock
• Shock
• Shock, Septic
• Supraventricular Arrhythmia

Intervention

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

Locations

Country	Name	City	State
Czechia	Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University	Prague 10
Czechia	Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University	Prague 2

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of propafenone	cardioversion rate	1 year
Primary	ICU mortality of septic shock patients on propafenone for a SV arrhythmia	ICU mortality	1 year
Primary	28-day mortality of septic shock patients on propafenone for a SV arrhythmia	28-day mortality	2 years
Primary	12-month mortality of septic shock patients on propafenone for a SV arrhythmia	12-month mortality	2 years
Secondary	Electromechanics of left atrium	left atrial emptying	1 year
Secondary	Electromechanics of LA	isovolumic and ejection times	1 year