<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/NCT03299517</url>
  </required_header>
  <id_info>
    <org_study_id>PSInCor-AMIOLIDO-VT</org_study_id>
    <nct_id>NCT03299517</nct_id>
  </id_info>
  <brief_title>PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT</brief_title>
  <acronym>AMIOLIDO-VT</acronym>
  <official_title>PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Introduction: Recent studies have suggested that other medications may be superior to&#xD;
      amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized&#xD;
      comparison with lidocaine has not yet been described.&#xD;
&#xD;
      Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone&#xD;
      versus lidocaine in patients with stable ventricular tachycardias.&#xD;
&#xD;
      Methodology: For this, a unicentric, randomized and prospective study will be carried out, in&#xD;
      which the two drugs will be administered in a comparative manner. Hospital data (test&#xD;
      results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed&#xD;
      for safety and effectiveness.&#xD;
&#xD;
      Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and&#xD;
      reversion of stable ventricular tachycardias.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">August 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Signs of peripheral hypoperfusion and shock</measure>
    <time_frame>1 hour</time_frame>
    <description>hypoperfusion and shock</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Signs of pulmonary congestion</measure>
    <time_frame>1 hour</time_frame>
    <description>dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severe hypotension</measure>
    <time_frame>1 hour</time_frame>
    <description>systolic blood pressure &lt;70 mmHg if the previous one is &lt;100 mmHg or systolic blood pressure &lt;80 mmHg if the previous one is &gt; 100 mmHg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HR increase</measure>
    <time_frame>1 hour</time_frame>
    <description>HR increase&gt; 20 bpm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The appearance of polymorphic TV.</measure>
    <time_frame>1 hour</time_frame>
    <description>polymorphic TV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lowering the level of consciousness.</measure>
    <time_frame>1 hour</time_frame>
    <description>glasgow &lt; 15</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>effectiveness of reversal</measure>
    <time_frame>1 hour</time_frame>
    <description>sinusal rhythm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time required for reversal</measure>
    <time_frame>1 hour</time_frame>
    <description>sinusal rhythm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Arrhythmias Ventricular</condition>
  <arm_group>
    <arm_group_label>lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes).&#xD;
Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amiodarone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes)&#xD;
Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antiarrythmic Drugs</intervention_name>
    <description>Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.</description>
    <arm_group_label>lidocaine</arm_group_label>
    <other_name>lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antiarrhythmic drugs</intervention_name>
    <description>Patient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.</description>
    <arm_group_label>amiodarone</arm_group_label>
    <other_name>amiodarone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men and women&gt; 18 years old&#xD;
&#xD;
          -  Presence of sustained ventricular tachycardia with HR&gt; 120 bpm&#xD;
&#xD;
          -  Systolic blood pressure&gt; 90 mmHg&#xD;
&#xD;
          -  No signs of poor peripheral perfusion&#xD;
&#xD;
          -  Absence of dyspnea&#xD;
&#xD;
          -  Absence of severe angina&#xD;
&#xD;
          -  Signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Body mass index greater than 40 kg / m2&#xD;
&#xD;
          -  Use of intravenous amiodarone or lidocaine in the last 24 hours&#xD;
&#xD;
          -  Acute coronary syndrome&#xD;
&#xD;
          -  Presence of tachycardia with irregular or supraventricular RR&#xD;
&#xD;
          -  Contraindications to study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Soeiro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidade Clínica de Emergência</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexandre Soeiro, MD</last_name>
    <phone>1126615299</phone>
    <email>alexandre.soeiro@bol.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto do Coração - HMFMUSP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre Soeiro, MD</last_name>
      <phone>5511-2661-5299</phone>
      <email>alexandre.soeiro@bol.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Somberg JC, Bailin SJ, Haffajee CI, Paladino WP, Kerin NZ, Bridges D, Timar S, Molnar J; Amio-Aqueous Investigators. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002 Oct 15;90(8):853-9. doi: 10.1016/s0002-9149(02)02707-8.</citation>
    <PMID>12372573</PMID>
  </results_reference>
  <results_reference>
    <citation>Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.</citation>
    <PMID>26472995</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lidocaine</keyword>
  <keyword>amiodarone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Amiodarone</mesh_term>
    <mesh_term>Anti-Arrhythmia Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03299517
org study id: PSInCor-AMIOLIDO-VT
nct id: NCT03299517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Recent studies have suggested that other medications may be superior to
      amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized
      comparison with lidocaine has not yet been described.

      Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone
      versus lidocaine in patients with stable ventricular tachycardias.

      Methodology: For this, a unicentric, randomized and prospective study will be carried out, in
      which the two drugs will be administered in a comparative manner. Hospital data (test
      results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed
      for safety and effectiveness.

      Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and
      reversion of stable ventricular tachycardias.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Signs of peripheral hypoperfusion and shock
time frame: 1 hour
description: hypoperfusion and shock
measure: Signs of pulmonary congestion
time frame: 1 hour
description: dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
measure: Severe hypotension
time frame: 1 hour
description: systolic blood pressure <70 mmHg if the previous one is <100 mmHg or systolic blood pressure <80 mmHg if the previous one is > 100 mmHg).
measure: HR increase
time frame: 1 hour
description: HR increase> 20 bpm.
measure: The appearance of polymorphic TV.
time frame: 1 hour
description: polymorphic TV.
measure: Lowering the level of consciousness.
time frame: 1 hour
description: glasgow < 15
measure: effectiveness of reversal
time frame: 1 hour
description: sinusal rhythm
measure: time required for reversal
time frame: 1 hour
description: sinusal rhythm
arm group label: lidocaine
arm group type: Experimental
description: Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes).
Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).
arm group label: amiodarone
arm group type: Experimental
description: Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes)
Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)
intervention type: Drug
intervention name: Antiarrythmic Drugs
description: Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
arm group label: lidocaine
other name: lidocaine
intervention type: Drug
intervention name: Antiarrhythmic drugs
description: Patient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
arm group label: amiodarone
other name: amiodarone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre Soeiro, MD
role: Principal Investigator
affiliation: Unidade Clínica de Emergência
last name: Alexandre Soeiro, MD
phone: 1126615299
email: alexandre.soeiro@bol.com.br
facility: 
status: Recruiting
contact: 
country: Brazil
citation: Somberg JC, Bailin SJ, Haffajee CI, Paladino WP, Kerin NZ, Bridges D, Timar S, Molnar J; Amio-Aqueous Investigators. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002 Oct 15;90(8):853-9. doi: 10.1016/s0002-9149(02)02707-8.
PMID: 12372573
citation: Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
PMID: 26472995
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
mesh term: Lidocaine
mesh term: Amiodarone
mesh term: Anti-Arrhythmia Agents
sharing ipd: Undecided