Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287209
Status:
COMPLETED
Last Update Posted:
2006-02-06
First Post:
2006-02-03
Brief Title:
Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting RASCABG 1 Study
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting RASCABG 1 Study
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether postoperatively oral treatment with high dosis amiodarone for five days after intravenously admitted bolusinfusion will minimize the risk for development of atrial fibrillation after coronary artery bypass grafting
Detailed Description:
New-onset atrial fibrillation AF after coronary bypass grafting CABG is common with an incidence ranging from 5-65
Although postoperative atrial tachyarrhythmia is often regarded as a temporary problem related to the operation and therefore innocuous this complication has clinically significant adverse effects on patient outcome
The purpose of this study was to find a good treatment without severe adverse effects to minimize the incidence of AF and maybe reduced the hemodynamic stress which AF is well known to cause This would indicate that the risk of developing fatal events like cerebral apoplexy TCI AMI and death will be minimized as a result of the improved hemodynamic
Overall AF is associated with risk of illness and for the development of severe complications as cerebral apoplexy TCI AMI and death with a factor 2-3
There has furthermore been seen a twofold increase in the duration of intensive care unit stay and prolongation of the total hospitalization time with attendant increased hospitalization cost
The outbreak of AF after CABG has been increasing over the last twenty years It is speculated that the reason for this rise in incidence is due to the advancing age in the patient populations more complex cardiac surgery as due to former underestimation of the arrhythmia
Medical therapy includes various drugs such as β-blockers calcium channel blockers digoxin sotalol quinidine and amiodarone among others to control heart rate and restore sinus rhythm Most of these antiarrhythmic agents have significant cardiac and noncardiac adverse effects why the use of these drugs should be minimized to a short period of time Amiodarone is well known drug to treat AF and diminish the incidence of AF after CABG operation So far there has not been any study focusing on postoperative high doses treatment with oral administrated amiodarone The studies which have been publicized are studies where the drug was administrated intravenously pre- post- or both pre- and postoperative Some studies have orally administrated the drug in different regimes11 but no study has yet shown the possible affect of solitarily postoperative administrated high doses amiodarone after an intravenously administrated bolus with the affect of getting loaded immediately
Although postoperative atrial tachyarrhythmia is often regarded as a temporary problem related to the operation and therefore innocuous this complication has clinically significant adverse effects on patient outcome
The purpose of this study was to find a good treatment without severe adverse effects to minimize the incidence of AF and maybe reduced the hemodynamic stress which AF is well known to cause This would indicate that the risk of developing fatal events like cerebral apoplexy TCI AMI and death will be minimized as a result of the improved hemodynamic
Overall AF is associated with risk of illness and for the development of severe complications as cerebral apoplexy TCI AMI and death with a factor 2-3
There has furthermore been seen a twofold increase in the duration of intensive care unit stay and prolongation of the total hospitalization time with attendant increased hospitalization cost
The outbreak of AF after CABG has been increasing over the last twenty years It is speculated that the reason for this rise in incidence is due to the advancing age in the patient populations more complex cardiac surgery as due to former underestimation of the arrhythmia
Medical therapy includes various drugs such as β-blockers calcium channel blockers digoxin sotalol quinidine and amiodarone among others to control heart rate and restore sinus rhythm Most of these antiarrhythmic agents have significant cardiac and noncardiac adverse effects why the use of these drugs should be minimized to a short period of time Amiodarone is well known drug to treat AF and diminish the incidence of AF after CABG operation So far there has not been any study focusing on postoperative high doses treatment with oral administrated amiodarone The studies which have been publicized are studies where the drug was administrated intravenously pre- post- or both pre- and postoperative Some studies have orally administrated the drug in different regimes11 but no study has yet shown the possible affect of solitarily postoperative administrated high doses amiodarone after an intravenously administrated bolus with the affect of getting loaded immediately
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None