ABBRUPT
The development of NOAF in ICU is associated with a several unwanted side effects including an increased risk of myocardial events, stroke and death in the twelve months following ICU discharge. Retrospective studies suggest that management with amiodarone (when compared with beta blockade) is associated with worse outcomes. There is however concern that these data are biased as patients who are cardiovascularly stable could have been excluded from receiving beta blockers. The ABBRUPT trial will study the widest possible population of critically ill patients in ICU as the impact of NOAF management on 90-day mortality is unknown.
INCLUSION CRITERIA
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Patient in an adult ICU (age ≥16 years)
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Onset of NOAF during the acute illness (A&E, deterioration on ward, after surgery) having previously been in sinus rhythm and not known to previously have had AF.
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A minimum duration of AF of at least 30 minutes
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Usual electrolyte management with potassium and magnesium according to site practice
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A clinical indication to treat NOAF as determined by the attending clinician
EXCLUSION CRITERIA
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Any known previous documented history of AF, whether permanent, persistent or paroxysmal
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Receipt of amiodarone or a beta-blocker in the previous 24 hours
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Current concomitant medication with treatments that are contraindicated with the intervention / comparator medications
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Serum Potassium of < 4 mmol L-1
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Serum Magnesium of <1.0 mmol L-1 (NOTE - if Mg is low you can give Mg and then randomize WITHOUT rechecking level)
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Patients having undergone cardiac surgery during the current hospital admission, defined as any surgery including stent procedures such as percutaneous coronary interventions or other angioplasty procedures done on the heart muscle, valves or thoracic arteries including the thoracic part of the aorta
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Thyrotoxicosis
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Withdrawal of life support therapy within 24 hours
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Other thoracic surgery that ingresses the thorax
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Any other known contraindication or known sensitivity to beta-blockers or amiodarone
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Known pregnancy or patients currently known to be breast-feeding
Study Information
Note- If rate is NOT controlled or there is NOT chemical cardioversion
with the allocated treatment then it is NOW permitted to use the alternate
therapy (amiodarone or beta-blockade. The protocol is being updated in relation to this.
