Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Vitamin C
* Drug: L-Carnitine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing on-pump cardiac surgery Exclusion Criteria: Off-pump cardiac surgery procedure AF before the procedure Recent infection and/or infectious endocarditis Presence of neoplasia Chronic renal failure with creatinine>2.3 mg/dl Hepatic failure Autoimmune disease and/or disease that brings about a systematic inflammatory response Thyroid disease Systematic use of supplements that contain vitC or carnitine The use of NSAIDs other than aspirin for a time period up to one month before the procedure

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-Carnitine<br>L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days | Drug: L-Carnitine<br>* L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days<br>|
| Active Comparator: Vitamin C<br>VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days | Drug: Vitamin C<br>* VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days<br>|
| Active Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Cardiac valve repair, Aneurysm repair, CABG, On-pump, Cardiac surgery, Vitamin C