<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029169</url>
  </required_header>
  <id_info>
    <org_study_id>1691/16 S-IV</org_study_id>
    <nct_id>NCT03029169</nct_id>
  </id_info>
  <brief_title>Propafenone Versus Amiodarone in Septic Shock</brief_title>
  <acronym>PRASE</acronym>
  <official_title>Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their&#xD;
      presence and management are related to patient´s prognosis. 1c class antiarrhythmics are&#xD;
      seldom administered in intensive care due to a dose dependent toxicity published in case&#xD;
      reports and unfavourable outcome reported in a few prospective trials done on cardiology&#xD;
      patients. The papers on 1c class antiarrhythmics do not take into consideration a complex&#xD;
      haemodynamic assessment using echocardiography. The authors have recently presented a&#xD;
      retrospective study on SV arrhythmias in septic shock patients demonstrating favourable&#xD;
      effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety&#xD;
      of propafenone, in a prospective blinded randomized trial performed in two large intensive&#xD;
      care units. Secondary aims are to monitor the electromechanics of left atrium in patients&#xD;
      with SV arrhythmias in septic shock.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 4, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Provided by a dedicated study nurse</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of propafenone</measure>
    <time_frame>1 year</time_frame>
    <description>cardioversion rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU mortality of septic shock patients on propafenone for a SV arrhythmia</measure>
    <time_frame>1 year</time_frame>
    <description>ICU mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>28-day mortality of septic shock patients on propafenone for a SV arrhythmia</measure>
    <time_frame>2 years</time_frame>
    <description>28-day mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12-month mortality of septic shock patients on propafenone for a SV arrhythmia</measure>
    <time_frame>2 years</time_frame>
    <description>12-month mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electromechanics of left atrium</measure>
    <time_frame>1 year</time_frame>
    <description>left atrial emptying</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electromechanics of LA</measure>
    <time_frame>1 year</time_frame>
    <description>isovolumic and ejection times</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Supraventricular Arrhythmia</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Propafenone i.v.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
Intervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amiodarone i.v.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
Intervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propafenone i.v.</intervention_name>
    <description>Treatment</description>
    <arm_group_label>Propafenone i.v.</arm_group_label>
    <other_name>Antiarrhythmic therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amiodarone i.v.</intervention_name>
    <description>Treatment</description>
    <arm_group_label>Amiodarone i.v.</arm_group_label>
    <other_name>Antiarrhythmic therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Septic shock with a new onset SV arrhythmia&#xD;
&#xD;
          -  LV systolic function normal to moderately reduced according to echocardiography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe LV systolic dysfunction&#xD;
&#xD;
          -  More than 1st degree AV block&#xD;
&#xD;
          -  High dose vasopressor therapy with continuous noradrenaline &gt; 1.0 ug/kg.min&#xD;
&#xD;
          -  Known intolerance to amiodarone or propafenone&#xD;
&#xD;
          -  Absence of septic shock&#xD;
&#xD;
          -  Chronic AF&#xD;
&#xD;
          -  Dependence on pacemaker&#xD;
&#xD;
          -  Status after MAZE procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Balik, A/Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Anaesthesia and Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University</name>
      <address>
        <city>Prague 10</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University</name>
      <address>
        <city>Prague 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Martin Balik</investigator_full_name>
    <investigator_title>A/Prof, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Supraventricular Arrhythmia</keyword>
  <keyword>Septic shock</keyword>
  <keyword>Propafenone</keyword>
  <keyword>Amiodarone</keyword>
  <keyword>Intensive Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amiodarone</mesh_term>
    <mesh_term>Anti-Arrhythmia Agents</mesh_term>
    <mesh_term>Propafenone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029169
org study id: 1691/16 S-IV
nct id: NCT03029169
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Provided by a dedicated study nurse
measure: Efficacy of propafenone
time frame: 1 year
description: cardioversion rate
measure: ICU mortality of septic shock patients on propafenone for a SV arrhythmia
time frame: 1 year
description: ICU mortality
measure: 28-day mortality of septic shock patients on propafenone for a SV arrhythmia
time frame: 2 years
description: 28-day mortality
measure: 12-month mortality of septic shock patients on propafenone for a SV arrhythmia
time frame: 2 years
description: 12-month mortality
measure: Electromechanics of left atrium
time frame: 1 year
description: left atrial emptying
measure: Electromechanics of LA
time frame: 1 year
description: isovolumic and ejection times
arm group label: Propafenone i.v.
arm group type: Active Comparator
description: 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.
arm group label: Amiodarone i.v.
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Propafenone i.v.
description: Treatment
arm group label: Propafenone i.v.
other name: Antiarrhythmic therapy
intervention type: Drug
intervention name: Amiodarone i.v.
description: Treatment
arm group label: Amiodarone i.v.
other name: Antiarrhythmic therapy
criteria: 
gender: All
minimum age: 16 Years
maximum age: 90 Years
healthy volunteers: No
last name: Martin Balik, A/Prof
role: Principal Investigator
affiliation: Dept of Anaesthesia and Intensive Care
facility: 
facility: 
country: Czechia
country: Czech Republic
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Martin Balik
investigator title: A/Prof, MD, PhD
mesh term: Shock, Septic
mesh term: Arrhythmias, Cardiac
mesh term: Shock
mesh term: Amiodarone
mesh term: Anti-Arrhythmia Agents
mesh term: Propafenone
sharing ipd: No