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| Sponsor: | Purdue University |
|---|---|
| Collaborator: |
Indiana University |
| Information provided by: | Purdue University |
| ClinicalTrials.gov Identifier: | NCT00127712 |
Purpose
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: amiodarone - for prophylaxis of atrial fibrillation Other: Control |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery |
| Enrollment: | 130 |
| Study Start Date: | September 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Amiodarone: Experimental
Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
|
Drug: amiodarone - for prophylaxis of atrial fibrillation
Control - no prophylaxis with amiodarone
|
|
Control: No Intervention
Control group
|
Other: Control
Control
|
Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).
A major complication of these non-cardiac open-chest surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following major non-cardiac open-chest surgery can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following non-cardiac open-chest surgery is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following non-cardiac open-chest surgery is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important.
Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following non-cardiac open-chest surgery has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in patients undergoing these procedures. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | James E Tisdale, PharmD | Department of Pharmacy Practice- School of Pharmacy and Pharmacal Sciences- Purdue University |
More Information
| Responsible Party: | Purdue University ( James Tisdale ) |
| Study ID Numbers: | 0407-16 |
| Study First Received: | August 4, 2005 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00127712 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
amiodarone atrial fibrillation surgical procedures, thoracic |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |