PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

NCT03299517 | Unknown Phase 4

• 1 other identifier: PSInCor-AMIOLIDO-VT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias Ventricular

Keywords

lidocaine; amiodarone

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• effectiveness of reversal

  1 hour

• time required for reversal

  1 hour

Study Arms (2)

lidocaine

EXPERIMENTAL

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

amiodarone

EXPERIMENTAL

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

Interventions

Antiarrythmic Drugs DRUG

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.

Also known as: lidocaine

lidocaine

Antiarrhythmic drugs DRUG

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.

Also known as: amiodarone

amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (2)

• 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 RESULT

• 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.

  PMID: 26472995 RESULT

MeSH Terms

Interventions

Lidocaine; Anti-Arrhythmia Agents; Amiodarone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexandre Soeiro, MD

  Unidade Clínica de Emergência

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

1126615299; alexandre.soeiro@bol.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: August 2, 2017
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2022
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

BR (1)