Phase 4
Completed N=80
Prevention of Atrial Fibrillation Following Esophagectomy
Source: ClinicalTrials.gov NCT00420017 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Feb 2013
Primary outcomePrimary: Incidence of Atrial Fibrillation — 6; 16 participants — p=0.02
Summary
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:
Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Atrial Fibrillation |
6; 16 | 0.02 sig |
| SECONDARY Length of Post-surgical Hospital Stay |
11; 12 | 0.31 |
| SECONDARY Length of Post-surgical Intensive Care Unit Stay |
68; 77 | 0.097 |
| SECONDARY Number of Participants With Adverse Effects |
21; 19 | 0.66 |
Eligibility Criteria
Inclusion Criteria
- Males or females over the age of 40
- Scheduled to undergo esophagectomy
Exclusion Criteria
- History of atrial fibrillation
- Prior severe side effects from amiodarone
- Elevated liver enzymes >3 times the upper limit of normal (UNL)
- Corrected QT interval > 450 ms
- Receiving class Ia or class III antiarrhythmics
Data sourced from ClinicalTrials.gov (NCT00420017). 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. Informational only — not medical advice.