Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery (FISH)
|Atrial Fibrillation||Drug: Omega Three Polyunsaturated fatty acids||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial|
- The primary endpoint is the development of postoperative atrial fibrillation or flutter after bypass surgery. [ Time Frame: 14 days ]The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
- Time to post-operative atrial fibrillation. [ Time Frame: 14 days ]ICU and hospital lengths of stay, re-operation; bleeding, stroke, peri-operative myocardial infarction, re-hospitalization for any cardiovascular problem, Time to atrial fibrillation, Death.
|Study Start Date:||February 2007|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: fish oil , corn oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
Drug: Omega Three Polyunsaturated fatty acids
2 grams orally twice daily pre-operatively and 2 grams oraly daily after until primary endpoint or 14 days.
Other Name: Lovaza, Omega three polyunsaturate ethyl esters
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446966
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52246|
|Study Chair:||Chirag M Sandesara, MD||Virginia Cardiovascular Associates|