CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 130 enrolled
Drug / intervention
Amiodaronedrug
Likely dose
Not stated in record
Key inclusion· 2
  • Age over 40 years
  • Scheduled for pneumonectomy or lobectomy
Key exclusion· 5
  • History of atrial fibrillation
  • Prior severe side effects from amiodarone
  • Elevated liver enzymes >3× upper limit of normal
  • QTc interval >450 ms

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127712
NCT00127712Phase 4Completed

Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

Indiana University·interventional·Posted Aug 8, 2005·Updated Sep 18, 2013

In Brief

A Phase 4 clinical trial evaluating Amiodarone for Atrial Fibrillation. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPurdue University

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2005
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.9 years ago

Interventions

Amiodaronedrug