Vitamin C and Atrial Fibrillation After Cardiac Surgery
The purpose of this study is to determine if vitamin C decreases the chance of developing atrial fibrillation, a type of arrhythmia or irregular heartbeat, following cardiac surgery. This irregular heartbeat is a common occurrence following cardiac surgery, and occurs in about one third of patients. It poses extra risks to people who develop it. Our hypothesis is that Vitamin C will decrease the incidence of postoperative atrial fibrillation.
Drug: Ascorbic Acid
Other: Identical Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery|
- Post-operative atrial fibrillation [ Time Frame: Patients will be followed for the entire hospital stay, with an expected average of 5 days ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Intensive care unit length of stay [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Stroke [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Transient ischemic attack [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Hospital Readmission for atrial fibrillation [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Experimental: Ascorbic acid||
Drug: Ascorbic Acid
Two 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days.
Other Name: Vitamin C
|Placebo Comparator: Placebo||
Other: Identical Placebo
Two capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days.
The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.
While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580683
|Contact: Scott Bolesta, Pharm.D.||firstname.lastname@example.org|
|Contact: Lear Von Koch, M.D.||email@example.com|
|United States, Pennsylvania|
|Regional Hospital of Scranton||Active, not recruiting|
|Scranton, Pennsylvania, United States, 18510|
|Principal Investigator:||Scott Bolesta, Pharm.D.||Wilkes University|