Coronary Artery Bypass Grafting, Coronary Artery Disease, Postoperative Atrial Fibrillation
Conditions
Keywords
Bisoprolol, Dosage regimens, heart rate, blood pressure
Brief summary
The goal of this interventional clinical trial is compare between two different dose regimens of bisoprolol (beta-blocker) in CABG patients in terms of efficacy and safety.
Interventions
DRUGBisoprolol
Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients: 18 to 65 years old * Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery
Exclusion criteria
* History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III * History of Sick sinus syndrome, sinoatrial heart block * History of valve replacement * Permanent Pacemaker * LVEF less than 30% * Unstable Heart failure * Cardiogenic shock * Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment * Severe chronic obstructive airway disease * Severe asthma unless was on previously tolerated bisoprolol dose * Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose * Pregnant/Lactation * Previous recent stroke * Creatinine clearance less than 30 ml/min * End stage liver disease (liver cirrhosis) * Drug dependance history * Untreated phaeochromocytoma * Vasospastic angina * Thyrotoxicosis * History of advanced staged of peripheral vascular disease * Hypersensitivity * Patients on any other beta-blocker other than bisoprolol * Patients on bisoprolol higher than 5 mg/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate | 5 days | Incidence of Atrial Fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Atrial Fibrillation | 5 days | Time at which event recurred. |
| Mean reduction in heart rate | Hospital stay ( up to 10 days) | Mean of reduction between two arms. |
| Mean resting heart rate | Hospital stay ( up to 10 days) | mean resting heart rate between two arms. |
| Mean systolic and diastolic blood pressure | Hospital stay (up to 10 days) | Mean systolic and diastolic blood pressure between two arms. |
| Length of ICU stay | ICU stay (up to 5 days) | time spent in the from ICU admission to ICU discharge |
| Onset time of Atrial Fibrillation | 5 days | Time at which event happened. |
| Medication safety | Hospital stay (up to 10 days) | Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes |
| Bisoprolol concentration | time before next dose post average 24 hours | Bisoprolol concentration between two arms |
| Use of inotropes/vasopressors | ICU stay (up to 5 days) | compare use of inotropes/vasopressors between the two arms. |
| ICU mortality | ICU stay (up to 5 days) | Number of death during ICU stay |
| Hospital Mortality | Hospital Stay (up to 10 days) | Number of death during hospital stay |
| Length of Hospital stay | Hospital stay (up to 10 days) | time spent in the hospital till discharge |
Countries
Egypt
Contacts
Primary ContactReem Ihab, Bsc
Outcome results
None listed