NCT03715556

Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

Prospective, Randomized and Blind Comparative Analysis Between Attraction of Restrict Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Septic Shock
• Atrial Fibrillation
• Ventricular Fibrillation
• Atrial Fibrillation Rapid

Interventions

Type	Name	Description
DRUG	Amiodarone	Administration of the drug will be blinded within the first 48 hours for the principal investigator. Amiodarone (5 mg / kg EV in 30 minutes) will be the drug of choice in the Restricted group blinded to the principal investigator. If there is no reversal / control and there is no adverse event, a further dose of the same previously administered medicinal product will be performed within 30 minutes, amiodarone 3 mg / kg. After the second dose, continuous infusion of amiodarone at a dose of 900 mg in 24 hours will be initiated.
DRUG	0.9% physiological solution	Administration of 0.9% physiological solution.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2018-10-23
• Last updated: 2018-10-23

Locations

1 site across 1 country: Brazil