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

What Was Tested

This registered phase 3 trial tested L-Carnitine.

It had three arms (groups): L-Carnitine (active comparator), Vitamin C (active comparator) and Placebo (active comparator).

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

The registry classes the interventions as drug.

More on the Plan

The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates.

A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 15 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients undergoing on-pump cardiac surgery.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: off-pump cardiac surgery procedure; AF before the procedure; recent infection and/or infectious endocarditis.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-04 with completion listed for 2015-04.

It ran at 1 site in Greece.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Incidence of Postoperative Atrial Fibrillation (time frame: Within the first 30 days (plus or minus 3 days)).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the L-Carnitine compound page, all human trials.