Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.
Data have demonstrated that critically ill patients with septic shock who develop atrial fibrillation suffer a greater likelihood of death and other complications when compared with patients who remain in sinus rhythm, however, little evidence exists to inform treatment strategies in this population. Ours is a pilot study evaluating rhythm vs rate control strategies in patients with septic shock and respiratory failure requiring invasive mechanical ventilation who develop new onset atrial fibrillation (NOAF). Design will be prospective, randomized, open-label. Patients in the rhythm control arm will receive IV amiodarone infusion followed by attempt at electrical cardioversion within 24 hours development of NOAF. Those in the rate control arm will receive negative chronotropic agents (beta blockers, calcium channel blockers, amiodarone, or digoxin) at the discretion of the treating physician. Available patient data will be collected for a total of 180 days following enrollment, and outcomes assessed will include ICU length of stay, ventilator free days, and time on vasopressors
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Amiodarone IV
Amiodarone tablet
Convert arrhythmia back to sinus rhythm
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
ICU Length of Stay (LOS)
Number of days patient was in the ICU
Time frame: 28 days
Ventilation-free days
Days alive and free from mechanical ventilation
Time frame: 28 days
Vasopressor days
If vasopressors are administered, number of days patient received vasopressors in the ICU
Time frame: 28 days
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one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin