Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: amiodarone

• Registration Number: NCT01461733
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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

see above

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Status Verified: 2014-09
• Results First Submitted: 2014-09-09
• Results First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Results First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• new onset afib

Exclusion Criteria

• hemodynamically unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
amiodarone	amiodarone	standard dose amiodarone

Primary Outcome Measures

Name	Time	Method
Conversion From Atrial Fibrillation to Sinus Rhythm	From randomization to conversion or ICU discharge up to 100 months.	Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.