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

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ClinicalTrials.gov Identifier: NCT01107730
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : May 13, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Polymeropoulos Evangelos, Attikon Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vitamin C Drug: L-Carnitine Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Primary Completion Date : April 2015
Study Completion Date : April 2015


Arm Intervention/treatment
Active Comparator: L-Carnitine
L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
Drug: L-Carnitine
L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
Active Comparator: Vitamin C
VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
Drug: Vitamin C
VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
Active Comparator: Placebo Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Incidence of Postoperative Atrial Fibrillation [ Time Frame: Within the first 30 days (plus or minus 3 days) ]
    The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.



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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107730


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

Publications:
Responsible Party: Polymeropoulos Evangelos, Dr, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01107730     History of Changes
Other Study ID Numbers: 268/27-07-09
First Posted: April 21, 2010    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015

Keywords provided by Polymeropoulos Evangelos, Attikon Hospital:
Atrial fibrillation
Cardiac valve repair
Aneurysm repair
CABG
On-pump
Cardiac surgery
Vitamin C

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