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

This study has been terminated.
(Unable to accrual total number of participants during study period.)
Sponsor:
Information provided by (Responsible Party):
Malcolm DeCamp, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00300495
First received: March 8, 2006
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Atrial Fibrillation Lung Cancer Drug: Amiodarone Other: Control arm, standard care Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Malcolm DeCamp, Beth Israel Deaconess Medical Center:

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


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


Enrollment: 19
Actual Study Start Date: February 2006
Study Completion Date: October 13, 2009
Primary Completion Date: October 13, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300495

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Malcolm M DeCamp, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Malcolm DeCamp, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00300495     History of Changes
Other Study ID Numbers: 2005P000376
Study First Received: March 8, 2006
Results First Received: March 20, 2017
Last Updated: March 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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

ClinicalTrials.gov processed this record on September 21, 2017