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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once Daily Regimen | Active Comparator | Patients who take bisoprolol 5 mg per day. |
|
| Twice Daily Regimen | Experimental | Patients who take bisoprolol 2.5 mg twice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate | Incidence of Atrial Fibrillation | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of Atrial Fibrillation | Time at which event happened. | 5 days |
| Recurrence of Atrial Fibrillation | Time at which event recurred. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reem Ihab, Bsc | Contact | +0201144481391 | reem.ihab@pharma.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Reem Ihab, Bsc | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El-Demerdash Cardiac Academy Hospital | Recruiting | Cairo | Egypt |
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| Bisoprolol | Drug | Bisoprolol was taken as 5 mg per day from hospital admission till discharge. |
|
| 5 days |
| Mean reduction in heart rate | Mean of reduction between two arms. | Hospital stay ( up to 10 days) |
| Mean resting heart rate | mean resting heart rate between two arms. | Hospital stay ( up to 10 days) |
| Mean systolic and diastolic blood pressure | Mean systolic and diastolic blood pressure between two arms. | Hospital stay (up to 10 days) |
| Length of ICU stay | time spent in the from ICU admission to ICU discharge | ICU stay (up to 5 days) |
| Length of Hospital stay | time spent in the hospital till discharge | Hospital stay (up to 10 days) |
| Medication safety | Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes | Hospital stay (up to 10 days) |
| Bisoprolol concentration | Bisoprolol concentration between two arms | time before next dose post average 24 hours |
| Use of inotropes/vasopressors | compare use of inotropes/vasopressors between the two arms. | ICU stay (up to 5 days) |
| ICU mortality | Number of death during ICU stay | ICU stay (up to 5 days) |
| Hospital Mortality | Number of death during hospital stay | Hospital Stay (up to 10 days) |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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