Study Stopped
No funding obtained to support patient recruitment
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2012
Typical duration for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 13, 2015
May 1, 2015
3 years
April 13, 2012
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative atrial fibrillation
Patients will be followed for the entire hospital stay, with an expected average of 5 days
Secondary Outcomes (6)
Hospital length of stay
30 Days
Intensive care unit length of stay
30 Days
Stroke
30 Days
Transient ischemic attack
30 Days
Mortality
30 Days
- +1 more secondary outcomes
Study Arms (2)
Ascorbic acid
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adults 50 years of age or older
- Undergoing elective or urgent coronary artery bypass graft surgery, valve surgery, or a combination of the two
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regional Hospital of Scranton
Scranton, Pennsylvania, 18510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Bolesta, Pharm.D.
Wilkes University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor or Pharmacy Practice and Clinical Pharmacist, Internal Medicine/Critical Care
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 19, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
May 13, 2015
Record last verified: 2015-05