New Onset Atrial Fibrillation, Respiratory Failure, Sepsis
Conditions
Keywords
new onsent atrial fibrillation, sepsis, critical care, direct current cardioversion, atrial fibrillation treatment
Brief 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
Interventions
DRUGAmiodarone in Parenteral Dosage Form
Amiodarone IV
DRUGAmiodarone Pill
Amiodarone tablet
PROCEDUREDirect Current Cardioversion (DCC)
Convert arrhythmia back to sinus rhythm
DRUGRate-control therapy
one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin
Sponsors
Our Lady of the Lake Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay (LOS) | 28 days | Number of days patient was in the ICU |
| Ventilation-free days | 28 days | Days alive and free from mechanical ventilation |
| Vasopressor days | 28 days | If vasopressors are administered, number of days patient received vasopressors in the ICU |
Countries
United States
Contacts
Primary ContactHollis R O'Neal, MD
Outcome results
None listed