Patient scheduled for elective cardiac surgery using cardiopulmonary bypass, treated with landiolol for the prevention of postoperative atrial fibrillation.
Conditions
Brief summary
First episode of postoperative atrial fibrillation occurring within the 7 postoperative days. Postoperative atrial fibrillation is defined as the de novo onset of postoperative atrial fibrillation, lasting more than 5 minutes and diagnosed on the electrocardiographic tracing from continuous intensive care unit monitoring (bedside monitor) and/or on the review of the 7-day Holter recording.
Detailed description
Occurrence of postoperative atrial fibrillation during the hospital stay up to 30 days following cardiac surgery, Time from ICU admission to the first episode of atrial fibrillation, Heart rate recorded hourly during the 72 hours following cardiac surgery, Blood pressure recorded hourly during the 72 hours following cardiac surgery, Proportion of time during which heart rate (HR) is controlled (60 ≤ HR < 80 bpm) within the 72 hours following cardiac surgery, Time from ICU admission to the first recurrence of atrial fibrillation, Length of ICU stay, Length of hospital stay, Serious adverse events: Severe bradycardia / Severe hypotension/ Ventricular tachycardia or ventricular fibrillation requiring specific treatment /Atrioventricular block requiring cardiac pacing/TIA or stroke Myocardial infarction /Cardiogenic Shock/Cardiac arrest/Renal failure requiring dialysis/ all-cause mortality
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First episode of postoperative atrial fibrillation occurring within the 7 postoperative days. Postoperative atrial fibrillation is defined as the de novo onset of postoperative atrial fibrillation, lasting more than 5 minutes and diagnosed on the electrocardiographic tracing from continuous intensive care unit monitoring (bedside monitor) and/or on the review of the 7-day Holter recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of postoperative atrial fibrillation during the hospital stay up to 30 days following cardiac surgery, Time from ICU admission to the first episode of atrial fibrillation, Heart rate recorded hourly during the 72 hours following cardiac surgery, Blood pressure recorded hourly during the 72 hours following cardiac surgery, Proportion of time during which heart rate (HR) is controlled (60 ≤ HR < 80 bpm) within the 72 hours following cardiac surgery, Time from ICU admission to the first recurrence of atrial fibrillation, Length of ICU stay, Length of hospital stay, Serious adverse events: Severe bradycardia / Severe hypotension/ Ventricular tachycardia or ventricular fibrillation requiring specific treatment /Atrioventricular block requiring cardiac pacing/TIA or stroke Myocardial infarction /Cardiogenic Shock/Cardiac arrest/Renal failure requiring dialysis/ all-cause mortality | — |