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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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