Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection

March 20, 2017 updated by: Malcolm DeCamp, Beth Israel Deaconess Medical Center

Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resectable lung nodule or mass

Exclusion Criteria:

  • Allergy to amiodarone
  • Currently taking amiodarone
  • Documented atrial fibrillation within past 12 months
  • Known pulmonary fibrosis
  • Known hepatic dysfunction
  • Thyroid disease
  • 2nd or 3rd degree heart block
  • Severe SA node disease
  • Bradycardia-induced syncope
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 - Amiodarone
Perioperative amiodarone
Drug: Amiodarone
Perioperative orally administered
Other Names:
  • Cordarone
  • Pacerone
Active Comparator: 2 - Control
Control arm, standard care with no perioperative amiodarone
Other: Control arm, standard care
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Post-operative Atrial Fibrillation
Time Frame: 30 days
Number of patients with post-operative atrial fibrillation
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Post-operative Hospital Stay
Time Frame: 1 week on average
Length of hospital stay after the operation
1 week on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Malcolm M DeCamp, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2006

Primary Completion (Actual)

October 13, 2009

Study Completion (Actual)

October 13, 2009

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria

March 8, 2006

First Posted (Estimate)

March 9, 2006

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005P000376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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