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

Attikon Hospital33 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Vitamin CDRUG

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

L-CarnitineDRUG

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

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 15 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University General Hospital Attikon

Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: Within the first 30 days (plus or minus 3 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.