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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac Surgery

NCT05063370

Right Heart Failure Open-heart Surgery

UNKNOWN PHASE2

Levosimendan Versus Milrinone in Off Pump CABG Surgery

NCT03855579

Hemodynamics

UNKNOWN PHASE4

Interest of Levosimendan Preconditioning for Cardiac Surgery Under CEC in Heart Failure Patients With Impaired Ejection Fraction

NCT06021587

Levosimendan Cardiac Surgery Heart Failure With Reduced Ejection Fraction

UNKNOWN

Preoperative Levosimendan in CABG Patients With Poor LV Function

NCT02184819

Coronary Artery Bypass Grafting Left Ventricular Dysfonction

COMPLETED PHASE3

Comparison Between Levosimendan and Adrenaline in CABG Patients

NCT05222256

Open Heart Surgery

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Low Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

levosemindan

this group of patients will recieve levosemindan

Group Type EXPERIMENTAL

levosemindan

Intervention Type 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.

traditional

this group of patients will recieve traditional intropic drugs

Group Type ACTIVE_COMPARATOR

adrenaline,noreadrenaline,dopamine and doputamine

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DRUG