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

Atrial Fibrillation Clinical Trial

Official title:

Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107730
• Other study ID #: 268/27-07-09
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2010
• Last updated: September 28, 2015
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital Attikon	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larraín E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Atrial Fibrillation	The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.	Within the first 30 days (plus or minus 3 days)	No