PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT (AMIOLIDO-VT)

PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM

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.

Study Overview

• Status: Unknown
• Conditions: Arrhythmias Ventricular
• Intervention / Treatment: Drug: Antiarrythmic Drugs; Drug: Antiarrhythmic drugs

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexandre Soeiro, MD; Phone Number: 1126615299; Email: alexandre.soeiro@bol.com.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403000
      • Recruiting
      • Instituto do Coração - HMFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult men and women> 18 years old
• Presence of sustained ventricular tachycardia with HR> 120 bpm
• Systolic blood pressure> 90 mmHg
• No signs of poor peripheral perfusion
• Absence of dyspnea
• Absence of severe angina
• Signed consent form

Exclusion Criteria:

• Pregnancy
• Hemodynamic instability
• Body mass index greater than 40 kg / m2
• Use of intravenous amiodarone or lidocaine in the last 24 hours
• Acute coronary syndrome
• Presence of tachycardia with irregular or supraventricular RR
• Contraindications to study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine; Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).	Drug: Antiarrythmic Drugs; 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.; Other Names: lidocaine
Experimental: amiodarone; Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)	Drug: Antiarrhythmic drugs; 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.; Other Names: amiodarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of peripheral hypoperfusion and shock	hypoperfusion and shock	1 hour
Signs of pulmonary congestion	dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.	1 hour
Severe hypotension	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).	1 hour
HR increase	HR increase> 20 bpm.	1 hour
The appearance of polymorphic TV.	polymorphic TV.	1 hour
Lowering the level of consciousness.	glasgow < 15	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of reversal	sinusal rhythm	1 hour
time required for reversal	sinusal rhythm	1 hour

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Alexandre Soeiro, MD, Unidade Clínica de Emergência

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Anticipated): August 2, 2019
• Study Completion (Anticipated): August 2, 2022

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: lidocaine; amiodarone
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Lidocaine; Amiodarone; Anti-Arrhythmia Agents
• Other Study ID Numbers: PSInCor-AMIOLIDO-VT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No