Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery (LANDIPROTEC)
Atrial Fibrillation, Cardiac Surgery
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Postoperative atrial fibrillation, Cardiac surgery, Landiolol hydrochloride, Low dose, Prophylactic administration
Eligibility Criteria
Inclusion Criteria:
- Non-Asian,
- Undergoing cardiac surgery with CPB,
- Left ventricular ejection fraction (LVEF) ≥ 40%,
- Having signed a written informed consent form,
- Affiliation to the social security system.
Preoperative Exclusion Criteria:
- Paroxystic or persistant atrial fibrillation before surgery,
- Preoperative contraindication to beta-blockers,
- Known hypersensitivity to landiolol,
- Severe conduction disorders (atrio-ventricular conduction block),
- A mental or linguistic inability to understand the study,
- Dying patient,
- Patient under protection of the adults (guardianship, curators or safeguard of justice),
- Patient included or planning to be included in another research protocol relating to medications.
Postoperative Exclusion Criteria:
- Postoperative contraindication to beta-blockers: severe sinus bradycardia requiring pacing, postcardiotomy low cardiac output requiring inotropic agents (noradrenaline being not considered as an inotropic agent), severe hypotension, severe acute pulmonary hypertension, reoperation for significant bleeding (> 200 ml/h), acute respiratory distress syndrome defined by increased oxygen dependence, a PaO2/FiO2 ratio < 200, polypnea > 30 /min, signs of respiratory distress (retractions, thoraco-abdominal asynchrony).
Sites / Locations
- Hôpital Privé Jacques Cartier
- CMC Ambroise Paré
- Centre Cardiologique du Nord
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Landiolol group
Placebo group
Landiolol infusion (2µg/kg/min) administrated after the surgery, on arrival at the ICU, until restoration of an effective oral beta-blocker treatment.
Saline solution infusion administrated after the surgery, on arrival at the ICU, until restoration of an effective oral beta-blocker treatment.