Treatment of Pulmonary Hypertension in High-risk Cardiac Surgery Patients Using Inhalational and Intravenous Agents (levos-milr)

Aretaieion University Hospital

Status: Enrolling

Conditions: Pulmonary Vascular Resistance Abnormality; Cardiac Failure; Hypertension, Pulmonary

Treatments: Drug: levosimendan at a dose of 6 mcg/kg; Drug: milrinone at a dose of 50 mcg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT04718350

levo-milri

Details and patient eligibility

About

The aim of this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.

Full description

Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure, which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.

In this study, the intravenous administration of Levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery.

In this setting, 40 patients with PH caused by left sided heart disease, will be assigned into two groups:

GROUP A: Intravenous administration of Levosimendan in dosage 6mcg/kg after induction of anesthesia.

GROUP B: Inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia.

Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used.

This study will lead to conclusions regarding the effectiveness of intravenous administration of Levosimendan and inhalational use of Milrinone in the treatment of right heart failure and PH in cardiac surgery patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
• elective cardiac surgery

Exclusion criteria

• primary pulmonary hypertension
• thromboembolic disease
• chronic obstructive pulmonary disease
• emergency surgery
• redo surgery
• inability to consent to the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Intravenous administration of Levosimendan at a dosage of 6 mcg/kg after induction of anesthesia

Active Comparator group

Description:

in this group, 6 mcg/kg of levosimendan will be administered intravenously after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass

Treatment:

Drug: levosimendan at a dose of 6 mcg/kg

Inhalational administration of Milrinone at a dosage of 50 mcg/kg after induction of anesthesia

Active Comparator group

Description:

in this group, 50 mcg/kg of milrinone will be administered via inhalation after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass

Treatment:

Drug: milrinone at a dose of 50 mcg/kg