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Phase 4 N=80 Randomized Prevention

Prevention of Atrial Fibrillation Following Esophagectomy

Atrial Fibrillation · Esophagectomy

Bottom Line

View on ClinicalTrials.gov: NCT00420017 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Feb 2013
Primary outcome: Primary: Incidence of Atrial Fibrillation — 6; 16 participants — p=0.02

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Amiodarone (Drug); Control (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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