NCT01107730

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 90 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Vitamin C	VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days
DRUG	L-Carnitine	L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-04-21
• Last updated: 2015-10-19
• Results posted: 2015-05-13

Locations

1 site across 1 country: Greece