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Status unknownNCT03299517AMIOLIDO-VTUpdated Oct 24, 2018

PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

A Phase 4 interventional study of Antiarrythmic Drugs and Antiarrhythmic drugs in Arrhythmias Ventricular, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arrhythmias Ventricular

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Keywords

  • lidocaine
  • amiodarone
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugAntiarrythmic 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.

    Also known as: lidocaine

  • DrugAntiarrhythmic 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.

    Also known as: amiodarone

05

What researchers measure

Primary outcomes

  1. Signs of peripheral hypoperfusion and shock

    hypoperfusion and shock

    Time frame: 1 hour

  2. Signs of pulmonary congestion

    dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.

    Time frame: 1 hour

  3. 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).

    Time frame: 1 hour

  4. HR increase

    HR increase\> 20 bpm.

    Time frame: 1 hour

  5. The appearance of polymorphic TV.

    polymorphic TV.

    Time frame: 1 hour

  6. Lowering the level of consciousness.

    glasgow \< 15

    Time frame: 1 hour

Secondary outcomes

  1. effectiveness of reversal

    sinusal rhythm

    Time frame: 1 hour

  2. time required for reversal

    sinusal rhythm

    Time frame: 1 hour

06

Study locations

1 of 1 sites recruiting
  • Instituto do Coração - HMFMUSP
    São Paulo, SP 05403000, Brazil
    Recruiting
07

References and documents

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. PubMed 12372573 ↗
  • 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. doi: 10.1161/CIR.0000000000000347. PubMed 26472995 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03299517
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Aug 2, 2017
Primary completion
Aug 2, 2019 (estimated)
Completion
Aug 2, 2022 (estimated)
Last update
Oct 24, 2018

Study contacts

Alexandre Soeiro, MD
Contact
alexandre.soeiro@bol.com.br
1126615299
Alexandre Soeiro, MD
principal investigator · Unidade Clínica de Emergência

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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