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

Attikon University Hospital

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: L-Carnitine; Drug: Placebo; Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01107730

268/27-07-09

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 15 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups

L-Carnitine

Active Comparator group

Description:

L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days

Treatment:

Drug: L-Carnitine

Vitamin C

Active Comparator group

Description:

VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days

Treatment:

Drug: Vitamin C

Placebo

Active Comparator group

Treatment:

Drug: Placebo