Study of Amiodarone Given Before Lung Surgery to Prevent 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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: January 2011
Intervention(s) in this Clinical Trial
- Drug: Amiodarone
- Perioperative orally administered
- Drug: Amiodarone
- Perioperative oral amiodarone
- Other: Control arm, standard care
- Control
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Perioperative amiodarone
- Active Comparator: 2
- Control arm, standard care with no perioperative amiodarone
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of post-operative atrial fibrillation
- Time Frame: 30 days
Safety Issue?: No
- Time Frame: 30 days
Secondary Measures
- Hospital charges
- Time Frame: 1 week on average
Safety Issue?: No
- Time Frame: 1 week on average
- Length of post-operative hospital stay
- Time Frame: 1 week on average
Safety Issue?: No
- Time Frame: 1 week on average
- Incidence of other post-operative complications
- Time Frame: 30 days
Safety Issue?: No
- Time Frame: 30 days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Beth Israel Deaconess Medical Center Other
Overall Clinical Trial Officials and Contacts
Malcolm M DeCamp, MD Principal Investigator Beth Israel Deaconess Medical Center
Overall Contact: Malcolm M DeCamp, MD 617-632-8386 mdecamp@bidmc.harvard.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300495
Study ID Number: 2005P000376
ClinicalTrials.gov Identifier: NCT00300495
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00300495
