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

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: L-Carnitine; Drug: Placebo; Drug: Vitamin C

• Registration Number: NCT01107730
• Lead Sponsor: Attikon Hospital

Brief 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2015-04-28
• Results First Submitted QC: 2015-04-28
• Results First Posted: 2015-05-13
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients undergoing on-pump cardiac surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Atrial Fibrillation	Within the first 30 days (plus or minus 3 days)	The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.

Trial Locations

Locations (1)

University General Hospital Attikon; 🇬🇷 Athens, Greece