Clinical trial NCT04092621: Rapid Atrial Fibrillation Treatment Strategy
Official title: Rapid Atrial Fibrillation Treatment Strategy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: New Onset Atrial Fibrillation
Sepsis
Respiratory Failure
Keywords: new onsent atrial fibrillation
sepsis
critical care
direct current cardioversion
atrial fibrillation treatment
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

Eligibility criteria: 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

Primary outcomes:
measure: ICU Length of Stay (LOS)
timeFrame: 28 days
measure: Ventilation-free days
timeFrame: 28 days
measure: Vasopressor days
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center
name: Hollis R O'Neal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meierhenrich R, Steinhilber E, Eggermann C, Weiss M, Voglic S, Bogelein D, Gauss A, Georgieff M, Stahl W. Incidence and prognostic impact of new-onset atrial fibrillation in patients with septic shock: a prospective observational study. Crit Care. 2010;14(3):R108. doi: 10.1186/cc9057. Epub 2010 Jun 10.
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citation: Mayr A, Ritsch N, Knotzer H, Dunser M, Schobersberger W, Ulmer H, Mutz N, Hasibeder W. Effectiveness of direct-current cardioversion for treatment of supraventricular tachyarrhythmias, in particular atrial fibrillation, in surgical intensive care patients. Crit Care Med. 2003 Feb;31(2):401-5. doi: 10.1097/01.CCM.0000048627.39686.79.
citation: Walkey AJ, Greiner MA, Heckbert SR, Jensen PN, Piccini JP, Sinner MF, Curtis LH, Benjamin EJ. Atrial fibrillation among Medicare beneficiaries hospitalized with sepsis: incidence and risk factors. Am Heart J. 2013 Jun;165(6):949-955.e3. doi: 10.1016/j.ahj.2013.03.020. Epub 2013 Apr 25.
citation: Arrigo M, Jaeger N, Seifert B, Spahn DR, Bettex D, Rudiger A. Disappointing Success of Electrical Cardioversion for New-Onset Atrial Fibrillation in Cardiosurgical ICU Patients. Crit Care Med. 2015 Nov;43(11):2354-9. doi: 10.1097/CCM.0000000000001257.
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