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Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock (NCT03029169)

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.
  • Drug: Propafenone i.v.
    Treatment
    • Antiarrhythmic therapy
  • Drug: Amiodarone i.v.
    Treatment
    • Antiarrhythmic therapy
Ages eligible for Study
16 Years to 90 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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
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.

1 locations

Czech Republic (1)
  • Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
    not yet recruiting
    Prague 2, Czech Republic, 128 08
Status:
not yet recruiting
Type:
Interventional
Phase:
Start:
31 January, 2017
Updated:
13 February, 2017
Participants:
100
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