NCT04092621

Rapid Atrial Fibrillation Treatment Strategy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Our Lady of the Lake Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• New Onset Atrial Fibrillation
• Sepsis
• Respiratory Failure

Interventions

Type	Name	Description
DRUG	Amiodarone in Parenteral Dosage Form	Amiodarone IV
DRUG	Amiodarone Pill	Amiodarone tablet
PROCEDURE	Direct Current Cardioversion (DCC)	Convert arrhythmia back to sinus rhythm
DRUG	Rate-control therapy	one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin

Timeline

• Start date: 2019-09-16
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2019-09-17
• Last updated: 2019-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study