NCT03029169

Propafenone Versus Amiodarone in Septic Shock

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Supraventricular Arrhythmia
• Septic Shock

Interventions

Type	Name	Description
DRUG	Propafenone i.v.	Treatment
DRUG	Amiodarone i.v.	Treatment

Timeline

• Start date: 2017-10-23
• Primary completion: 2022-07-04
• Completion: 2022-08-01
• First posted: 2017-01-24
• Last updated: 2022-08-02

Locations

2 sites across 1 country: Czechia