Clinical trial NCT03299517: PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT
Official title: PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arrhythmias Ventricular
Keywords: lidocaine
amiodarone
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Signs of peripheral hypoperfusion and shock
timeFrame: 1 hour
measure: Signs of pulmonary congestion
timeFrame: 1 hour
measure: Severe hypotension
timeFrame: 1 hour
measure: HR increase
timeFrame: 1 hour
measure: The appearance of polymorphic TV.
timeFrame: 1 hour
measure: Lowering the level of consciousness.
timeFrame: 1 hour
Secondary outcomes:
measure: effectiveness of reversal
timeFrame: 1 hour
measure: time required for reversal
timeFrame: 1 hour
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
state: SP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Alexandre Soeiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.