Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (AFIB)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
amiodarone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, amiodarone
Eligibility Criteria
Inclusion Criteria:
- new onset afib
Exclusion Criteria:
- hemodynamically unstable
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
amiodarone
placebo
Arm Description
standard dose amiodarone
Outcomes
Primary Outcome Measures
Conversion From Atrial Fibrillation to Sinus Rhythm
Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
Secondary Outcome Measures
Full Information
NCT ID
NCT01461733
First Posted
August 19, 2010
Last Updated
September 9, 2014
Sponsor
Ottawa Hospital Research Institute
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT01461733
Brief Title
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Acronym
AFIB
Official Title
Atrial Fibrillation WITHOUT Hemodynamic Stability
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, amiodarone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amiodarone
Arm Type
Experimental
Arm Description
standard dose amiodarone
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
amiodarone
Other Intervention Name(s)
non applicable
Intervention Description
standard dose amiodarone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo delivered blinded
Primary Outcome Measure Information:
Title
Conversion From Atrial Fibrillation to Sinus Rhythm
Description
Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
Time Frame
From randomization to conversion or ICU discharge up to 100 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
new onset afib
Exclusion Criteria:
hemodynamically unstable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salmaan Kanji, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
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