Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

Aretaieion University Hospital

Status: Completed

Conditions: Cardiac Surgery; Cardiac Failure; Cardiac Disease; Ejection Fraction; Inotropes

Treatments: Procedure: preoperative infusion of levosimendan; Procedure: no preoperative infusion of levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT04635293

667/24.02.2020

Details and patient eligibility

About

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery

Full description

Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective cardiac surgery
• cardiac surgery under cardiopulmonary bypass
• low ejection fraction (<40%)

Exclusion criteria

• age <18 years old
• urgent operation
• glomerular filtration rate<30 ml/min
• hepatic dysfunction preoperatively
• side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration
• redo surgery

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery

Active Comparator group

Treatment:

Procedure: preoperative infusion of levosimendan

patients who were not administered levosimendan prior to surgery

Placebo Comparator group

Treatment:

Procedure: no preoperative infusion of levosimendan