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The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Carnitine | Active Comparator | L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days |
|
| Vitamin C | Active Comparator | VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days |
|
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Atrial Fibrillation | The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo. | Within the first 30 days (plus or minus 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioannis Toumpoulis, MD | University of Athens Medical School, Attikon Hospital, Cardiology Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital Attikon | Athens | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19446899 | Result | Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larrain E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: 10.1016/j.ijcard.2009.04.043. Epub 2009 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | L-Carnitine | L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days |
| FG001 | Vitamin C | VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days |
| FG002 | Placebo | Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | L-Carnitine | Carnitine 2 days preoperatively and 4 days postoperatively |
| BG001 | Vitamin C | Vitamin C 2 days preoperatively and 4 days postoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postoperative Atrial Fibrillation | The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo. | Posted | Number | participants | Within the first 30 days (plus or minus 3 days) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | L-Carnitine | Carnitine 2 days preoperatively and 4 days postoperatively Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ioannis K. Toumpoulis | Attikon Hospital | 00306977243942 | toumpoul@otenet.gr |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| L-Carnitine | Drug | L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days |
|
| Placebo | Drug | Placebo |
|
| BG002 | Placebo | Placebo: Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo: Placebo
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Vitamin C | Vitamin C 2 days preoperatively and 4 days postoperatively Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively | 0 | 11 | 0 | 11 |
| EG002 | Placebo | Placebo: Placebo | 0 | 11 | 0 | 11 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |