Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

This study has been completed.
Information provided by (Responsible Party):
Polymeropoulos Evangelos, Attikon Hospital Identifier:
First received: April 20, 2010
Last updated: April 28, 2015
Last verified: April 2015

The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

Condition Intervention Phase
Atrial Fibrillation
Drug: Vitamin C
Drug: Carnitine
Drug: 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: Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Resource links provided by NLM:

Further study details as provided by Attikon Hospital:

Primary Outcome Measures:
  • Incidence of Postoperative Atrial Fibrillation [ Time Frame: Within the first 30 days (plus or minus 3 days) ] [ Designated as safety issue: No ]
    The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.

Enrollment: 33
Study Start Date: April 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-Carnitine
Carnitine 2 days preoperatively and 2 days postoperatively
Drug: Carnitine
Carnitine 2 days preoperatively and 2 days postoperatively
Active Comparator: Vitamin C
Vitamin C 2 days preoperatively and 2 days postoperatively
Drug: Vitamin C
Vitamin C 2 days preoperatively and 2 days postoperatively
Active Comparator: Placebo Drug: Placebo

Detailed Description:

Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.


Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing on-pump cardiac surgery

Exclusion Criteria:

  • Off-pump cardiac surgery procedure
  • AF before the procedure
  • Recent infection and/or infectious endocarditis
  • Presence of neoplasia
  • Chronic renal failure with creatinine>2.3 mg/dl
  • Hepatic failure
  • Autoimmune disease and/or disease that brings about a systematic inflammatory response
  • Thyroid disease
  • Systematic use of supplements that contain vitC or carnitine
  • The use of NSAIDs other than aspirin for a time period up to one month before the procedure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01107730

University General Hospital Attikon
Athens, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
Study Chair: Ioannis Toumpoulis, MD University of Athens Medical School, Attikon Hospital, Cardiology Department
  More Information

Responsible Party: Polymeropoulos Evangelos, Dr, Attikon Hospital Identifier: NCT01107730     History of Changes
Other Study ID Numbers: 268/27-07-09
Study First Received: April 20, 2010
Results First Received: April 28, 2015
Last Updated: April 28, 2015
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Attikon Hospital:
Atrial fibrillation
Cardiac valve repair
Aneurysm repair
Cardiac surgery
Vitamin C

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Ascorbic Acid
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex processed this record on May 31, 2015