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

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)

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Low Ejection Fraction
• Intervention / Treatment: Drug: levosemindan; Drug: adrenaline,noreadrenaline,dopamine and doputamine

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • El Sharkia
    • Zagazig, El Sharkia, Egypt, 44519
      • cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: levosemindan; this group of patients will recieve levosemindan	Drug: levosemindan; 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.
Active Comparator: traditional; this group of patients will recieve traditional intropic drugs	Drug: adrenaline,noreadrenaline,dopamine and doputamine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 )

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: levosemindan- low ejection fraction-cardiac surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Cardiotonic Agents; Dopamine Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Dopamine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: ZU-IRB # 737/15-oct-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No