Trial record 6 of 101 for:    Open Studies | "Ascorbic Acid"

Vitamin C and Atrial Fibrillation After Cardiac Surgery

This study is not yet open for participant recruitment.
Verified April 2012 by Regional Hospital of Scranton
Sponsor:
Information provided by (Responsible Party):
Scott Bolesta, Pharm.D., BCPS, Regional Hospital of Scranton
ClinicalTrials.gov Identifier:
NCT01580683
First received: April 13, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Ascorbic Acid
Other: Identical Placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Regional Hospital of Scranton:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 290
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580683

Contacts
Contact: Scott Bolesta, Pharm.D. 570-408-4203 scott.bolesta@wilkes.edu
Contact: Lear Von Koch, M.D. 570-343-1115 lvonkoch@epix.net

Locations
United States, Pennsylvania
Regional Hospital of Scranton Active, not recruiting
Scranton, Pennsylvania, United States, 18510
Sponsors and Collaborators
Regional Hospital of Scranton
Investigators
Principal Investigator: Scott Bolesta, Pharm.D. Wilkes University
  More Information

No publications provided

Responsible Party: Scott Bolesta, Pharm.D., BCPS, Associate Professor or Pharmacy Practice and Clinical Pharmacist, Internal Medicine/Critical Care, Regional Hospital of Scranton
ClinicalTrials.gov Identifier: NCT01580683     History of Changes
Other Study ID Numbers: WU0811SB
Study First Received: April 13, 2012
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Regional Hospital of Scranton:
Atrial Fibrillation
Ascorbic Acid
Thoracic Surgery
Cardiac Arrhythmias
Cardiac Surgery
Vitamin C
Postoperative Complications
Antioxidants
Inflammation

Additional relevant MeSH terms:
Ascorbic Acid
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014