Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction

Phase 2

Completed

• Conditions: Cardiac Surgery; Low Ejection Fraction
• Interventions: Drug: levosemindan; Drug: adrenaline,noreadrenaline,dopamine and doputamine

• Registration Number: NCT06784570
• Lead Sponsor: Zagazig University

Brief Summary

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)

Detailed Description

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)

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-08-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-12
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Valve surgery
2. CABG surgery,
3. combined surgery
4. all patients Ejection Fraction less than 35 ٪ -

Exclusion Criteria

1. Patients age ≤ 20-70 < years
2. Aortic and redo surgery
3. any patients with Ejection Fraction more than 35 ٪ -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levosemindan	levosemindan	this group of patients will recieve levosemindan
traditional	adrenaline,noreadrenaline,dopamine and doputamine	this group of patients will recieve traditional intropic drugs

Primary Outcome Measures

Name	Time	Method
death through day 30,	1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )	death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery
Renal-replacement therapy	1 month	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)
Perioperative myocardial infarction	5 days	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
Intra Aortic Ballon Pumb insertion	5 days(no scale for measurement )	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

Trial Locations

Locations (1)

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt; 🇪🇬 Zagazig, El Sharkia, Egypt