A Phase 3 interventional study of Amiodarone and 0.9% physiological solution in Sepsis, Septic Shock and Atrial Fibrillation, 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 2018-10-23.
Sponsored by University of Sao Paulo General Hospital · Phase 3, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 126 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Sao Paulo General Hospital is the lead sponsor of 595 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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Exclusion Criteria:
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. Administration of the drug will be blinded within the first hour to the principal investigator.
Drug: Amiodarone · Drug: 0.9% physiological solution
The Liberal group will receive only 0.9% physiological solution, also blinded to the principal investigator.
Drug: 0.9% physiological solution
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.
Administration of 0.9% physiological solution.
Complications of safety outcomes
Need for orotracheal intubation, Bradycardia requiring specific treatment or transvenous pacemaker, Confirmed embolic event, Need for association of another vasoactive drug or dose increase of already used vasoactive drug\> 50% of initial, Cardiorespiratory arrest, Death
Time frame: 48 hours
Effectiveness in the control of the heart rate
Comparison between the effectiveness in the control of the heart rate of AF among patients of the Restricted versus Liberal group. Effective control will be considered when the patient reaches heart rate \<100 bpm
Time frame: 48 hours
Plan to share: Undecided
No publications or documents are linked to this record.
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University of Sao Paulo General Hospital