Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)
in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levosemindan | Experimental | this group of patients will recieve levosemindan |
|
| traditional | Active Comparator | this group of patients will recieve traditional intropic drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levosemindan | Drug | In common practice the loading dose is omitted as it is associated with hypotension.9 Usual dose range: 0.05 to 0.2 microg/kg/min. Dose based on actual body weight up to a maximum of 120 kg.5 Commence infusion at 0.05 microg/kg/min. If the initial rate is tolerated, consider increasing the maintenance rate to 0.1 microg/kg/min after 60 minutes. If the patient remains haemodynamically stable, further increase the dose to 0.2 microg/kg/min for the remainder of the infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| death through day 30, | death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery | 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured ) |
| Renal-replacement therapy | included haemodialysis, peritoneal dialysis, or continuous Veno venous haemodialysis(indicated when serum creatinine above 2.0 mg/dl or an increase of 50% above baseline value) | 1 month |
| Perioperative myocardial infarction | defined as a creatine kinase MB level of more than 100 ng per millilitre or a level that was more than 10 times the upper limit of the normal range specified at the local laboratory, regardless of changes on the electrocardiogram, or a creatine kinase MB level that was more than 50 ng per millilitre or a level that was more than 5 times the upper limit of the normal range with new Q waves that were more than 30 msec in duration in two contiguous leads or new left bundle-branch block | 5 days |
| Intra Aortic Ballon Pumb insertion | it consisidered to be one of the ventricular assissted device that need to be inserted in post cardiac surgery shocked patiients that not respond heamdynamically to highest doses of cardiac intropes | 5 days(no scale for measurement ) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt | Zagazig | Sharqia Province | 44519 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
patients divided into three groups according to type of surgery done : CABG alone, Valve alone and combined each group contains 80 patients, then each previous group is subdivided into LEVO group and TRAD group each subgroup contain 40 patients according to the type of inotropes used in each group either levosemindane (pre operative ) or other traditional adrenergic drugs :adrenaline ,noradrenaline ,dopamine and dobutamine
Not provided
Not provided
Not provided
Not provided
|
| adrenaline,noreadrenaline,dopamine and doputamine | Drug | adrenaline:*4 9 %$ 0 ****8*4* 9 : ,- 4 - *4 9 * C % F*4 9 9 9 noreadrenaline:# *4 9 C % 9 F 9 9 *4* Q*4 9 9 dopamine:9 * C % 9 F 9 9 ) * 9 9 dobutamine:9 * C % F 9 9 9 * 9 9 |
|
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |