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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00300495
• Other study ID #: 2005P000376
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2006
• Last updated: May 5, 2008
• Start date: February 2006
• Est. completion date: March 2011

Study information

• Verified date: May 2008
• Source: Beth Israel Deaconess Medical Center
• Contact: Malcolm M DeCamp, MD
• Phone: 617-632-8386
• Email: mdecamp[@]bidmc.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Lung Cancer

Intervention

Drug:
• Amiodarone
Perioperative orally administered
• Amiodarone
Perioperative oral amiodarone

Other:
• Control arm, standard care
Control

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative atrial fibrillation		30 days	No
Secondary	Hospital charges		1 week on average	No
Secondary	Length of post-operative hospital stay		1 week on average	No
Secondary	Incidence of other post-operative complications		30 days	No