Phase 4
N=24
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01461733 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Conversion From Atrial Fibrillation to Sinus Rhythm — 8; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- amiodarone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conversion From Atrial Fibrillation to Sinus Rhythm |
8; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- new onset afib
Exclusion Criteria
- hemodynamically unstable
Data sourced from ClinicalTrials.gov (NCT01461733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.