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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Attikon Hospital
Sponsor:
Information provided by (Responsible Party):
Polymeropoulos Evangelos, Attikon Hospital
ClinicalTrials.gov Identifier:
NCT01107730
First received: April 20, 2010
Last updated: January 13, 2015
Last verified: January 2015
  Purpose

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: Open Label
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.


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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
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.

  Eligibility

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107730

Contacts
Contact: Evangelos A Polymeropoulos, MD +306977325325 varlaam@gmail.com

Locations
Greece
University General Hospital Attikon Recruiting
Athens, Greece, 12462
Principal Investigator: Evangelos A Polymeropoulos, MD         
Sponsors and Collaborators
Attikon Hospital
Investigators
Study Chair: Ioannis Rizos, MD University of Athens Medical School, Attikon Hospital, Cardiology Department
  More Information

Publications:
Responsible Party: Polymeropoulos Evangelos, Dr, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01107730     History of Changes
Other Study ID Numbers: 268/27-07-09
Study First Received: April 20, 2010
Last Updated: January 13, 2015
Health Authority: Greece: Ministry of Health and Welfare

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

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

ClinicalTrials.gov processed this record on February 27, 2015