Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446966
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2007-03-12
Brief Title:
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Sponsor:
Chirag Sandesara
Organization:
University of Iowa
Study Overview
Official Title:
Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery The Fish Trial
Status:
COMPLETED
Status Verified Date:
2018-09
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:
FISH
Brief Summary:
The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery In this placebo-controlled trial patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively The following hypotheses will be tested 1 omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation AF after cardiac surgery 2 omega-3 polyunsaturated fatty acids administered in the perioperative period for cardiac surgery decreases postoperative complication rates and 3 omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay
Detailed Description:
Atrial fibrillation is the most common complication after bypass surgery It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality Atrial fibrillation is also associated with an increased risk for strokes use of potentially harmful drugs and the need for pacemaker therapy
This study is for patients who are undergoing elective bypass surgery Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo prior to surgery After surgery treatment will continue until the primary endpoint atrial fibrillation is reached or 14 days whichever is first
This study is for patients who are undergoing elective bypass surgery Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo prior to surgery After surgery treatment will continue until the primary endpoint atrial fibrillation is reached or 14 days whichever is first
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