Perioperative atrial fibrillation (POAF) is the most common arryhthmia after cardiac surgery with incidences ranging from 20% to 40%, depending on various patient's risk factors and the type of surgery performed. It's not only causing problems in the immediate postoperative period due to hemodynamic instability and a increased need for catecholamines to stabilise the patient, it also leads to increased mortality and morbidity and longer hospital stays, increasing costs to healthcare system. Med
Conditions
Interventions
Trade Name: Rapibloc
Pharmaceutical Form: Powder for dispersion for infusion
CAS Number: 144481-98-1
Other descriptive name: LANDIOLOL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years old 2. Written informed consent from patient 3. Oral Betablocker in the patients long-term medication 4. Patient is in Sinusrhythm at screening 5. One of the following cardiac surgical procedures which is planned on cardiopulmonary bypass (CPB): a. Single valve surgery b. Single or multiple CABG procedures c. Single valve surgery in combination with one or multiple coronary artery bypass grafts (CABGs) d. Multiple valve surgery in combination with or without CABG e. Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG f. Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG 6. Cardiac surgery is performed electively Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: 1. Bodyweight > 101kg and/or BMI = 40 2. Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy) or planned as off-pump surgery 3. Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection of the atrial appendix or atrial resections during the surgery 4. Sinus bradycardia (resting heart rate 2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg) before initiation of study medication 13. More than 5 units of RBC necessary to maintain a haemoglobin level >8mg/dl at the end of surgery 14. Prior cardiac surgery within the past 6 months 15. History of heart transplantation or planned heart transplantation 16. Any other disease or condition that is likely to interfere with the evaluation of the study drug, outcome assessment or satisfactory conduct of the study: a. Active infective endocarditis b. Stroke or transient ischemic attack (TIA) within the last 6 months c. Concomitant disease with a life expectancy of less than 6 months d. Cardiopulmonary resuscitation within the last 4 weeks e. Patients requiring renal replacement therapy 17. Active infection on current systemic antibiotics and/ or temperature greater than 38°C at time of screening and before start of surgery 18. Haemoglobin < 5 mmol/l (< 8.06 g/dl) 19. Any systemic anti-cancer therapy within past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prevention of peri- and postoperative atrial fibrillation using landiolol hydrochloride in patients undergoing elective on-pump cardiac surgery;Secondary Objective: •Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery. •Hemodynamic stability during treatment with IMP •Length of ICU stay •Requirement of intensive respiratory and circulatory support •Peri- and postoperative mortality •Assessment of biomarkers as surrogate parameters for cardiac dysfunction •Impact of IMP on cardiac function •Incidence of serious adverse events ;Primary end point(s): The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery.;Timepoint(s) of evaluation of this end point: Continously per Holter ECG monitoring on the first seven days after operation. During the IMP application one ECG control per day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery. • Hemodynamic stability during treatment with IMP • Length of ICU stay • Requirement of intensive respiratory and circulatory support • Peri- and postoperative mortality • Assessment of biomarkers as surrogate parameters for cardiac dysfunction • Impact of IMP on cardiac function • Incidence of serious adverse events ;Timepoint(s) of evaluation of this end point: During visits at defined timepoints: Start of surgery End of surgery Start Holter ECG and Start of IMP (immediate after end of surgery) ICU-Admission 24h after ICU admission 48h after ICU admission 72h after ICU admission Day 7 Day 30 Follow up phone call | — |
Countries
Austria
Contacts
Public ContactKlin. Abt. für HTG-Anästhesie
Medical University of Vienna, Department of Anaesthesiology, Division of cardiothoracic and vascular anaesthesiology
Outcome results
None listed