Trial Outcomes & Findings for Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures (NCT NCT01107730)
NCT ID: NCT01107730
Last Updated: 2015-10-19
Results Overview
The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Within the first 30 days (plus or minus 3 days)
Results posted on
2015-10-19
Participant Flow
Participant milestones
| Measure |
L-Carnitine
L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days
|
Vitamin C
VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days
|
Placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
Baseline characteristics by cohort
| Measure |
L-Carnitine
n=11 Participants
Carnitine 2 days preoperatively and 4 days postoperatively
|
Vitamin C
n=11 Participants
Vitamin C 2 days preoperatively and 4 days postoperatively
|
Placebo
n=11 Participants
Placebo: Placebo
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Age, Continuous
|
75 years
n=99 Participants
|
64 years
n=107 Participants
|
65 years
n=206 Participants
|
66 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Greece
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
33 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Within the first 30 days (plus or minus 3 days)The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.
Outcome measures
| Measure |
L-Carnitine
n=11 Participants
Carnitine 2 days preoperatively and 4 days postoperatively
|
Vitamin C
n=11 Participants
Vitamin C 2 days preoperatively and 4 days postoperatively
|
Placebo
n=11 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Incidence of Postoperative Atrial Fibrillation
|
5 participants
|
4 participants
|
5 participants
|
Adverse Events
L-Carnitine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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