Principal Investigator : Dr Alain Vadeboncoeur
Local co-investigator: Éric Mercier, emergency physician, trauma team leader and clinical researcher at the Centre de Recherche du CHU de Québec-Université Laval
Co-investigator: Émond, M; Macle, L; Larose, D; Lucey, M; Pelletier, H; Sirois, J; Chamberland, ME; Bouchard, S; Baltazar, C; Rivard, LI; Dupriez, AF
Local nurse coordinator: Suzy Lavoie
Granting agency: Canadian Institutes of Health Research – CIHR and Fondation des maladies du coeur du Canada
recent study has shown that physicians use different approaches in treating arrhythmias similar to yours in Canada’s emergency departments. In addition, the Canadian Cardiovascular Society guidelines state that there are not enough studies to decide what is best. This is what the present study aims to determine.
Raff-2 is a randomized controlled study to compare electrical cardioversion to pharmacologic cardioversion in patients admitted to emergency departments with sudden onset fibrillation or flutter.
It is a research, that is, doctors want to determine whether an approach with procainamide, a drug used in emergency departments, followed if necessary by cardioversion, is preferable to another approach to cardioversion alone, Also approved and currently used in emergency services. Both of these treatment methods are approved by Health Canada and regularly used in our facility for the treatment of arrhythmia.
This is a randomized, double-blind trial comparing procainamide to a placebo. This phase aims to demonstrate whether the addition of this drug is superior to the only electrical cardioversion (electrical shock treating the arrhythmia). There will be a one in two chance of receiving procainamide (Group 1) or placebo (no active drug) (Group 2).
If the arrhythmia is not resolved 30 minutes after receiving procainamide (or placebo) a cardioversion will be performed by the attending physician in the emergency room, assisted by an anesthetist or a second emergency physician.