Rapid Atrial Fibrillation Treatment Strategy (RAFTS)

Our Lady of the Lake Hospital

Status and phase: Unknown; Phase 4

Conditions: Respiratory Failure; New Onset Atrial Fibrillation; Sepsis

Treatments: Drug: Rate-control therapy; Drug: Amiodarone in Parenteral Dosage Form; Drug: Amiodarone Pill; Procedure: Direct Current Cardioversion (DCC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04092621

19-106

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No history of atrial fibrillation
• Meet Sepsis-3 criteria
• New onset atrial fibrillation in the ICU
• Atrial fibrillation treatment warranted
• Anticoagulation therapy not contraindicated
• On a ventilator
• Patient or family member willing to provide informed consent to participate in study

Exclusion criteria

• Post-cardiac or thoracic surgery
• Hemodynamically unstable
• Unable to tolerate anticoagulation
• Physician provider does not agree for patient to participate in study
• Patient or family member unwilling or unable to provide informed consent
• Expected death within 24 hours
• Non-English speakers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Rhythm-control strategy

Experimental group

Description:

The patient will receive 1) amiodarone 150mg bolus over ten minutes followed by intravenous (IV) 1mg/min for 6 hours and then 0.5mg/min for 18hours, and 2) direct current cardioversion (DCC) at the completion of initial 6 hour IV bolus or within 24 hours of new onset of atrial fibrillation. Patient will be placed on by mouth amiodarone 400mg three times daily for seven days, then 400mg twice daily for seven days, then 400mg once daily for seven days, then 200mg daily until stop date which will be by provider discretion after discharge from ICU. If the patient does not convert to a normal sinus rhythm with routine DCC then they will remain in the rhythm-control strategy to receive amiodarone as directed. Amiodarone may be extended at discretion of provider for 30 days with discontinuation if adverse effects. If no contraindications, anticoagulation will be recommended prior to DCC with enoxaparin 1mg/kg every 12 hours.

Treatment:

Procedure: Direct Current Cardioversion (DCC)

Drug: Amiodarone Pill

Drug: Amiodarone in Parenteral Dosage Form

Rate-control strategy

Active Comparator group

Description:

At treating physician's discretion, one of the following, or a combination of the following, will be administered to the patient: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin. The target heart rate is less than 120 beats per minute (bpm) or maintained hemodynamics. Patients in the rate-control arm who are hypotensive after new onset atrial fibrillation can undergo DCC at the provider's discretion and crossover into the rhythm-control arm.

Treatment:

Drug: Rate-control therapy