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Investigating the clinical and cost-effectiveness of two different drugs (amiodarone and beta blockers) to treat patients with new-onset atrial fibrillation whilst in the intensive care unit

Phase 3
Conditions
ew onset atrial fibrillation (NOAF)
Circulatory System
Registration Number
ISRCTN59775011
Lead Sponsor
niversity of Birmingham
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
2560
Inclusion Criteria

1. Patients in an adult ICU (age =16 years)
2. 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.
3. A minimum duration of AF of at least 30 minutes
4. Usual electrolyte management with potassium and magnesium according to site practice
5. A clinical indication to treat NOAF as determined by the attending clinician

Exclusion Criteria

1. Patients in receipt of amiodarone or a beta-blocker in the previous 24 hours
2. Patients receiving current concomitant medication with treatments that are contraindicated with the intervention/comparator medications
3. Patients with a serum potassium of <4 mmol L-1
4. Patients with a serum magnesium of <1.0 mmol L-1
5. 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
6. Patients with Thyrotoxicosis
7. Patients where there is a plan for withdrawal of life support therapy within 24 hours
8. Patients who have had other thoracic surgery that ingresses the thorax
9. Patients with any other known contraindication or known sensitivity to beta-blockers or amiodarone
10. Patients with a known pregnancy or patients currently known to be breastfeeding
11. Patients with any known previous documented history of AF, whether permanent, persistent or paroxysmal

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
90 day mortality measured using patient records
Secondary Outcome Measures
NameTimeMethod
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