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Completed

NCT Number: NCT03029169

Propafenone Versus Amiodarone in Septic Shock

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.

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Key information

Conditions

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

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propafenone i.v.

Drug

Treatment

Other names: Antiarrhythmic therapy

Amiodarone i.v.

Drug

Treatment

Other names: Antiarrhythmic therapy

Primary outcomes

  1. Efficacy of propafenone

    Time frame: 1 year

    cardioversion rate

  2. ICU mortality of septic shock patients on propafenone for a SV arrhythmia

    Time frame: 1 year

    ICU mortality

  3. 28-day mortality of septic shock patients on propafenone for a SV arrhythmia

    Time frame: 2 years

    28-day mortality

  4. 12-month mortality of septic shock patients on propafenone for a SV arrhythmia

    Time frame: 2 years

    12-month mortality

Secondary outcomes

  1. Electromechanics of left atrium

    Time frame: 1 year

    left atrial emptying

  2. Electromechanics of LA

    Time frame: 1 year

    isovolumic and ejection times

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Acronym: PRASE

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2017
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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