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Clinical Trial Summary

Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03715556
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Alexandre Soeiro, MD
Phone +55112661-5299
Email alexandre.soeiro@bol.com.br
Status Not yet recruiting
Phase Phase 3
Start date December 1, 2018
Completion date December 1, 2021

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