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

Primary Purpose

Arrhythmias Ventricular

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Antiarrythmic Drugs
Antiarrhythmic drugs
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias Ventricular focused on measuring lidocaine, amiodarone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Coração - HMFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lidocaine

amiodarone

Arm Description

Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).

Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)

Outcomes

Primary Outcome Measures

Signs of peripheral hypoperfusion and shock
hypoperfusion and shock
Signs of pulmonary congestion
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
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).
HR increase
HR increase> 20 bpm.
The appearance of polymorphic TV.
polymorphic TV.
Lowering the level of consciousness.
glasgow < 15

Secondary Outcome Measures

effectiveness of reversal
sinusal rhythm
time required for reversal
sinusal rhythm

Full Information

First Posted
September 27, 2017
Last Updated
October 23, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03299517
Brief Title
PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT
Acronym
AMIOLIDO-VT
Official Title
PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN PATIENTS WITH STABLE VENTRICULAR TACHYCARDIA IN THE EMERGENCY ROOM
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
August 2, 2019 (Anticipated)
Study Completion Date
August 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias Ventricular
Keywords
lidocaine, amiodarone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lidocaine
Arm Type
Experimental
Arm Description
Initial dose: antiarrythmic drugs Lidocaine (1.5 mg / kg EV in 30 minutes). Adittional dose: Lidocaine (0.75 mg / kg EV in 30 minutes).
Arm Title
amiodarone
Arm Type
Experimental
Arm Description
Initial dose: antiarrythmic drugs Amiodarone (5 mg / kg EV in 30 minutes) Adittional dose: Amiodarone (3 mg / kg EV in 30 minutes)
Intervention Type
Drug
Intervention Name(s)
Antiarrythmic Drugs
Other Intervention Name(s)
lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drugs
Other Intervention Name(s)
amiodarone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Signs of peripheral hypoperfusion and shock
Description
hypoperfusion and shock
Time Frame
1 hour
Title
Signs of pulmonary congestion
Description
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Time Frame
1 hour
Title
Severe hypotension
Description
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
Title
HR increase
Description
HR increase> 20 bpm.
Time Frame
1 hour
Title
The appearance of polymorphic TV.
Description
polymorphic TV.
Time Frame
1 hour
Title
Lowering the level of consciousness.
Description
glasgow < 15
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
effectiveness of reversal
Description
sinusal rhythm
Time Frame
1 hour
Title
time required for reversal
Description
sinusal rhythm
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Soeiro, MD
Phone
1126615299
Email
alexandre.soeiro@bol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Soeiro, MD
Organizational Affiliation
Unidade Clínica de Emergência
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coração - HMFMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Soeiro, MD
Phone
5511-2661-5299
Email
alexandre.soeiro@bol.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12372573
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.
Results Reference
result
PubMed Identifier
26472995
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. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
Results Reference
result

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PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT

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