Phase 4
N=130
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00127712 ↗Enrolled (actual)
130
Serious AEs
2.3%
Results posted
Mar 2010
Primary outcome: Primary: Incidence of Atrial Fibrillation Requiring Treatment — 9; 21 participants — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amiodarone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Atrial Fibrillation Requiring Treatment |
9; 21 | 0.02 sig |
| PRIMARY Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds |
9; 22 | 0.001 sig |
| SECONDARY Length of Intensive Care Unit Stay |
46; 84 | 0.03 sig |
| SECONDARY Length of Hospital Stay |
7; 8 | 0.79 |
Summary
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:
* Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
* Determine the influence of the prevention of AF following non-cardiac thoracic surgery on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical duration of stay in a hospital unit that employs cardiac monitoring; and duration of post-surgical hospital stay; and
* Determine the safety of amiodarone for the prevention of AF following non-cardiac open-chest surgery.
Eligibility Criteria
Inclusion Criteria
- Males or females over the age of 40
- Scheduled to undergo pneumonectomy or lobectomy
Exclusion Criteria
- History (hx) of atrial fibrillation
- Prior severe side effects from amiodarone
- Elevated liver enzymes >3 times the upper limit of normal (UNL)
- QTc interval > 450 ms
- Receiving class Ia or class III antiarrhythmics
Data sourced from ClinicalTrials.gov (NCT00127712). 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.