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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Attikon Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Attikon Hospital
ClinicalTrials.gov Identifier:
NCT01107730
First received: April 20, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  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
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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: 87
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin C I
VitC will be administered (2g/day [500mgX4] per os for 2 days prior to surgery, and intravenous administration postoperatively for 2 days and per os administration until discharge from the hospital).
Drug: Vitamin C
VitC 2g/day [500mgX4]
Active Comparator: Vitamin C II
VitC will be administered (intravenous administration postoperatively for 2 days and per os administration until discharge from the hospital).
Drug: Vitamin C
VitC 2g/day [500mgX4]
Placebo Comparator: Placebo
Placebo will be administered (NaCl 0.9%: 5ml 1X4, 2 days prior to surgery and until discharge from hospital).
Drug: Vitamin C
VitC 2g/day [500mgX4]

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

Locations
Greece
University General Hospital Attikon
Athens, Greece, 12462
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: Evangelos Polymeropoulos MD, Korgialeneio-Mpenakeio National Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01107730     History of Changes
Other Study ID Numbers: 268/27-07-09
Study First Received: April 20, 2010
Last Updated: April 20, 2010
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014