search
Back to results

Vitamin C and Atrial Fibrillation After Cardiac Surgery

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ascorbic Acid
Identical Placebo
Sponsored by
Regional Hospital of Scranton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Ascorbic Acid, Thoracic Surgery, Cardiac Arrhythmias, Cardiac Surgery, Vitamin C, Postoperative Complications, Antioxidants, Inflammation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital of Scranton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ascorbic acid

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Post-operative atrial fibrillation

Secondary Outcome Measures

Hospital length of stay
Intensive care unit length of stay
Stroke
Transient ischemic attack
Mortality
Hospital Readmission for atrial fibrillation

Full Information

First Posted
April 13, 2012
Last Updated
May 11, 2015
Sponsor
Regional Hospital of Scranton
search

1. Study Identification

Unique Protocol Identification Number
NCT01580683
Brief Title
Vitamin C and Atrial Fibrillation After Cardiac Surgery
Official Title
Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No funding obtained to support patient recruitment
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital of Scranton

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Ascorbic Acid, Thoracic Surgery, Cardiac Arrhythmias, Cardiac Surgery, Vitamin C, Postoperative Complications, Antioxidants, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ascorbic acid
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Identical Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative atrial fibrillation
Time Frame
Patients will be followed for the entire hospital stay, with an expected average of 5 days
Secondary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
30 Days
Title
Intensive care unit length of stay
Time Frame
30 Days
Title
Stroke
Time Frame
30 Days
Title
Transient ischemic attack
Time Frame
30 Days
Title
Mortality
Time Frame
30 Days
Title
Hospital Readmission for atrial fibrillation
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Bolesta, Pharm.D.
Organizational Affiliation
Wilkes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital of Scranton
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vitamin C and Atrial Fibrillation After Cardiac Surgery

We'll reach out to this number within 24 hrs