Rapid Atrial Fibrillation Treatment Strategy

Study Overview
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Brief Summary
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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
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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

Official Title
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Rapid Atrial Fibrillation Treatment Strategy

Conditions
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New Onset Atrial Fibrillation, Sepsis, Respiratory Failure

Intervention / Treatment
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* Drug: Amiodarone in Parenteral Dosage Form
* Drug: Amiodarone Pill
* Procedure: Direct Current Cardioversion (DCC)
* Drug: Rate-control therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhythm-control strategy<br>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. | Drug: Amiodarone in Parenteral Dosage Form<br>* Amiodarone IV<br>* Other names: Cordarone;Drug: Amiodarone Pill<br>* Amiodarone tablet<br>* Other names: Cordarone;Procedure: Direct Current Cardioversion (DCC)<br>* Convert arrhythmia back to sinus rhythm<br>|
| Active Comparator: Rate-control strategy<br>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. | Drug: Rate-control therapy<br>* one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay (LOS) | Number of days patient was in the ICU | 28 days | 
| Ventilation-free days | Days alive and free from mechanical ventilation | 28 days | 
| Vasopressor days | If vasopressors are administered, number of days patient received vasopressors in the ICU | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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new onsent atrial fibrillation, sepsis, critical care, direct current cardioversion, atrial fibrillation treatment