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

NCT06784570 | Completed Phase 2 DMC

• 1 other identifier: ZU-IRB # 737/15-oct-2024
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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)

Conditions

Cardiac Surgery; Low Ejection Fraction

Keywords

levosemindan- low ejection fraction-cardiac surgery

Outcome Measures

Primary Outcomes (4)

• 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 )

Study Arms (2)

levosemindan

EXPERIMENTAL

this group of patients will recieve levosemindan

Drug: levosemindan

traditional

ACTIVE COMPARATOR

this group of patients will recieve traditional intropic drugs

Drug: adrenaline,noreadrenaline,dopamine and doputamine

Interventions

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.

levosemindan

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

traditional

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Valve surgery
• CABG surgery,
• combined surgery
• all patients Ejection Fraction less than 35 ٪ -

You may not qualify if:

• Patients age ≤ 20-70 \< years
• Aortic and redo surgery
• any patients with Ejection Fraction more than 35 ٪ -

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assis professor

Model Details: 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

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)