Prevention of Atrial Fibrillation Following Esophagectomy
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| ClinicalTrials.gov Identifier: NCT00420017 |
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Recruitment Status :
Completed
First Posted : January 9, 2007
Results First Posted : February 6, 2013
Last Update Posted : September 18, 2013
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The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:
Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Esophagectomy | Drug: Amiodarone Other: Control | Phase 4 |
Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these 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 esophagectomy 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 esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy 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 esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Prevention of Atrial Fibrillation Following Thoracoabdominal Esophagectomy Surgery |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Amiodarone
Intravenous amiodarone
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Drug: Amiodarone
Intravenous amiodarone continuous infusion x 4 days |
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Control
Control
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Other: Control
No amiodarone |
- Incidence of Atrial Fibrillation [ Time Frame: 7 days ]
- Length of Post-surgical Hospital Stay [ Time Frame: Duration of hospitalization ]
- Length of Post-surgical Intensive Care Unit Stay [ Time Frame: 7 days ]
- Number of Participants With Adverse Effects [ Time Frame: 7 days ]Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females over the age of 40
- Scheduled to undergo esophagectomy
Exclusion Criteria:
- History of atrial fibrillation
- Prior severe side effects from amiodarone
- Elevated liver enzymes >3 times the upper limit of normal (UNL)
- Corrected QT interval > 450 ms
- Receiving class Ia or class III antiarrhythmics
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): NCT00420017
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | James E Tisdale, PharmD | Purdue University |
| Responsible Party: | James E. Tisdale, Professor and Interim Head, Department of Pharmacy Practice, Purdue University, and Adjunct Professor, School of Medicine, Indiana University, Purdue University |
| ClinicalTrials.gov Identifier: | NCT00420017 |
| Other Study ID Numbers: |
0510-23 |
| First Posted: | January 9, 2007 Key Record Dates |
| Results First Posted: | February 6, 2013 |
| Last Update Posted: | September 18, 2013 |
| Last Verified: | September 2013 |
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Amiodarone Atrial fibrillation Surgical procedures, thoracic |
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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 |