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
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.
University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Signs of peripheral hypoperfusion and shock
hypoperfusion and shock
Time frame: 1 hour
Signs of pulmonary congestion
dyspnea, orthopnea, onset of pulmonary rales or drop in oximetry.
Time frame: 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).
Time frame: 1 hour
HR increase
HR increase\> 20 bpm.
Time frame: 1 hour
The appearance of polymorphic TV.
polymorphic TV.
Time frame: 1 hour
Lowering the level of consciousness.
glasgow \< 15
Time frame: 1 hour
effectiveness of reversal
sinusal rhythm
Time frame: 1 hour
time required for reversal
sinusal rhythm
Time frame: 1 hour
Plan to share: Undecided
Started Aug 2017 (actual). Primary completion is estimated for Aug 2019, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
University of Sao Paulo General Hospital →