Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate. The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

Detailed Description
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see above

Official Title
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Atrial Fibrillation WITHOUT Hemodynamic Stability

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: amiodarone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new onset afib Exclusion Criteria: hemodynamically unstable

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amiodarone<br>standard dose amiodarone | Drug: amiodarone<br>* standard dose amiodarone<br>* Other names: non applicable;|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* placebo delivered blinded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion From Atrial Fibrillation to Sinus Rhythm | Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days. | From randomization to conversion or ICU discharge up to 100 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, amiodarone