A Phase 2 interventional study of levosemindan and adrenaline,noreadrenaline,dopamine and doputamine in Cardiac Surgery and Low Ejection Fraction, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Zagazig University · Phase 2, Interventional, and Prevention
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)
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
this group of patients will recieve levosemindan
Drug: levosemindan
this group of patients will recieve traditional intropic drugs
Drug: adrenaline,noreadrenaline,dopamine and doputamine
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.
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
death through day 30,
death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 5 days(no scale for measurement )
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Zagazig University