Vitamin C and Atrial Fibrillation After Cardiac Surgery

Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing 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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Ascorbic Acid; Other: Identical Placebo

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Scranton, Pennsylvania, United States, 18510
      • Regional Hospital of Scranton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults 50 years of age or older
• Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two

Exclusion Criteria:

• Prior cardiac surgery
• History of atrial fibrillation
• Permanent or temporary pace maker
• Currently taking digoxin or Vaughan Williams Class I or III antiarrhythmic medications
• Known hyperoxaluria
• History of renal calculi
• History of allergic or hypersensitivity reaction to ascorbic acid products
• Currently taking 1 g or more of ascorbic acid supplementation daily

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: Vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative atrial fibrillation	Patients will be followed for the entire hospital stay, with an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 Days
Hospital length of stay	30 Days
Intensive care unit length of stay	30 Days
Stroke	30 Days
Transient ischemic attack	30 Days
Hospital Readmission for atrial fibrillation	30 Days

Collaborators and Investigators

• Sponsor: Regional Hospital of Scranton
• Investigators: Principal Investigator: Scott Bolesta, Pharm.D., Wilkes University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Antioxidants; Inflammation; Atrial Fibrillation; Ascorbic Acid; Cardiac Surgery; Vitamin C; Thoracic Surgery; Postoperative Complications; Cardiac Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: WU0811SB