Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (AFIB)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: amiodarone Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Atrial Fibrillation WITHOUT Hemodynamic Stability |
- conversion from atrial fibrillation to sinus rhythm [ Time Frame: From randomization to conversion or ICU discharge up to 100 months. ] [ Designated as safety issue: Yes ]Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
| Enrollment: | 25 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: amiodarone
standard dose amiodarone
|
Drug: amiodarone
standard dose amiodarone
Other Name: non applicable
|
| Placebo Comparator: placebo |
Drug: Placebo
placebo delivered blinded
|
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- new onset afib
Exclusion Criteria:
- hemodynamically unstable
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT01461733 History of Changes |
| Other Study ID Numbers: | NA5936 Heart and Stroke, OHREB Protocol # 2006430-01 |
| Study First Received: | August 19, 2010 |
| Last Updated: | May 28, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
atrial fibrillation amiodarone |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013