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

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ClinicalTrials.gov Identifier: NCT00300495
Recruitment Status : Terminated (Unable to accrual total number of participants during study period.)
First Posted : March 9, 2006
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Malcolm DeCamp, Beth Israel Deaconess Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Lung Cancer Drug: Amiodarone Other: Control arm, standard care Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
Actual Study Start Date : February 2006
Actual Primary Completion Date : October 13, 2009
Actual Study Completion Date : October 13, 2009

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Post-operative Atrial Fibrillation [ Time Frame: 30 days ]
    Number of patients with post-operative atrial fibrillation


Secondary Outcome Measures :
  1. Length of Post-operative Hospital Stay [ Time Frame: 1 week on average ]
    Length of hospital stay after the operation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300495


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Malcolm M DeCamp, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Malcolm DeCamp, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00300495    
Other Study ID Numbers: 2005P000376
First Posted: March 9, 2006    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malcolm DeCamp, Beth Israel Deaconess Medical Center:
Atrial fibrillation
Lung cancer
Pulmonary resection
Post-operative complications
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors