Trial Outcomes & Findings for Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery (NCT NCT00446966)
NCT ID: NCT00446966
Last Updated: 2018-10-10
Results Overview
The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
260 participants
Primary outcome timeframe
14 days
Results posted on
2018-10-10
Participant Flow
The recruitment period was from February 2007 to December 2009. Patients were recruited from cardiothoracic clinic.
Participant milestones
| Measure |
Fish Oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
|
Corn Oil
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
COMPLETED
|
120
|
123
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Fish Oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
|
Corn Oil
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
Baseline Characteristics
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Fish Oil
n=130 Participants
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
|
Corn Oil
n=130 Participants
Standard grade corn oil
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
62 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=5 Participants
|
130 participants
n=7 Participants
|
260 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Intention to treat
The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
Outcome measures
| Measure |
Corn Oil
n=130 Participants
Corn oil
|
Fish Oil
n=130 Participants
|
|---|---|---|
|
Number of Participants Who Developed Postoperative Atrial Fibrillation
|
33 participants
|
30 participants
|
Adverse Events
Fish Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corn Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place