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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00300495
First received: March 8, 2006
Last updated: May 5, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Incidence of post-operative atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital charges [ Time Frame: 1 week on average ] [ Designated as safety issue: No ]
  • Length of post-operative hospital stay [ Time Frame: 1 week on average ] [ Designated as safety issue: No ]
  • Incidence of other post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Perioperative amiodarone
Drug: Amiodarone
Perioperative orally administered
Drug: Amiodarone
Perioperative oral amiodarone
Active Comparator: 2
Control arm, standard care with no perioperative amiodarone
Other: Control arm, standard care
Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contacts
Contact: Malcolm M DeCamp, MD 617-632-8386 mdecamp@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Malcolm M DeCamp, MD    617-632-8386    mdecamp@bidmc.harvard.edu   
Principal Investigator: Malcolm M DeCamp, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Malcolm M DeCamp, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Malcolm DeCamp Jr., MD, BIDMC
ClinicalTrials.gov Identifier: NCT00300495     History of Changes
Other Study ID Numbers: 2005P000376
Study First Received: March 8, 2006
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Atrial fibrillation
Lung cancer
Pulmonary resection
Post-operative complications

Additional relevant MeSH terms:
Lung Neoplasms
Atrial Fibrillation
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014