PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

Arrhythmias Ventricular Clinical Trial

— AMIOLIDO-VT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299517
• Other study ID #: PSInCor-AMIOLIDO-VT
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2, 2017
• Est. completion date: August 2, 2022

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: 1126615299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias Ventricular

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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 — View 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signs of peripheral hypoperfusion and shock	hypoperfusion and shock	1 hour
Primary	Signs of pulmonary congestion	dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.	1 hour
Primary	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
Primary	HR increase	HR increase> 20 bpm.	1 hour
Primary	The appearance of polymorphic TV.	polymorphic TV.	1 hour
Primary	Lowering the level of consciousness.	glasgow < 15	1 hour
Secondary	effectiveness of reversal	sinusal rhythm	1 hour
Secondary	time required for reversal	sinusal rhythm	1 hour