cardiac complications during and after vascular surgery MedDRA version: 12.1 Level: LLT Classification code 10028601 Term: Myocardial ischemia
Conditions
Interventions
Trade Name: Brevibloc
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ESMOLOL HYDROCHLORIDE
CAS Number: 81161173
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Erasmus Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion for the study at the Erasmus Medical Centre if they are: 1. Scheduled for arterial vascular surgery, including abdominal aortic aneurysm repair, abdominal aortic stenosis surgery, lower limb arterial reconstruction or carotid artery stenosis repair 2. Provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential subjects will be excluded with any of the following: 1. Active bleeding 2. Untreated left main disease 3. Active cardiac condition such as unstable angina pectoris, active congestive heart failure, serious cardiac arrhythmias, symptomatic valvular disease, recent MI< 6 months. 4. Preoperative positive troponin T 5. Contraindication for esmolol use 6. Previous allergy or intolerance to esmolol 7. Cancer with an expected life expectancy < 6 months 8. Excessive alcohol use 9. Pregnancy or planning to become pregnant 10. Failure to provide informed consent 11.Failure to monitor heart rate with the continuous 12-lead electrocardiography because of surgery or baseline electrocardiographic abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare hemodynamic stability in patients treated with esmolol versus placebo as an add-on to standard perioperative care.;Secondary Objective: -to compare incidence of myocardial ischemia in patients treated with esmolol versus placebo as an add-on to standard perioperative care. -comparing safety parameters such as incidence of bradycardia, TIA and stroke in patients receiving esmolol and standard care versus placebo and standard care. ;Primary end point(s): The primary endpoint is hemodynamic stability during the first 24 hours after the start of surgery, where hemodynamic stability is defined as total length of heart rate outside the target window presented in minutes. The target window is defined as a heart rate between 60 and 80 beats per minute. If the heart rate is outside the target window, but without evidence of ischaemia, and esmolol or placebo is titrated at the maximum dose of 300 ug/kg/min, no additional actions will be taken, unless myocardial ischaemia is observed. I.e. if a patient does not experience myocardial ischaemia as assessed by electrocardiographic monitoring, no rescue medication will be provided. However, if the patient develops tachycardia with the presence of signs of ischaemia, a study endpoint is reached, and intervention with rescue medication is performed, in accordance with good clinical practices at the hospital. For those patients in whom the rescue medications were given, there is no additional statistical measurement will be considered to count for the minimum impact on the primary endpoint- differences in total length of heart rate outside the target heart rate window between two groups (bisoprolol vs. bisoprolol + esmolol). Since all patients who are receiving bisoprolol as a minimum standard of care are expected to have relatively low incident rate for signs of ischeamia where additional rescue medication would be used. | — |
Countries
Netherlands
Outcome results
None listed