Prevention of Atrial Fibrillation Following Esophagectomy

NCT00420017 ↗

Phase 4 Completed 80 enrolled Indiana University Indiana University Health · collab Purdue University · collab

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2005-09
Primary completion: 2008-11
Completion: 2008-11

Outcome

Met primary endpoint

registry Amiodarone vs Control; p = 0.02; Risk Ratio (RR) 0.38 (95% CI 0.16 to 0.86); Chi-squared NCT00420017 ↗

paper The incidence of atrial fibrillation requiring treatment was lower in the amiodarone group than in the control group (15% vs 40%, P = .02, PMID 20381077 ↗

Publications

Results Tisdale JE, Wroblewski HA, Wall DS, Rieger KM, Hammoud ZT, Young JV, Kesler KA. A randomized, controlled study of amiodarone for prevention of atrial fibrillation after transthoracic esophagectomy. J Thorac Cardiovasc Surg. 2010 Jul;140(1):45-51. doi: 10.1016/j.jtcvs.2010.01.026. Epub 2010 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amiodarone	Small molecule	4200 mg	Intravenous