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Completed

NCT Number: NCT04718350

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

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiac Failure Cardiovascular Diseases Heart Diseases Heart Failure Hypertension Lung Diseases Pulmonary Vascular Resistance Abnormality Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onassis Cardiac Surgery Center

Athens, 17674, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levosimendan at a dose of 6 mcg/kg

Drug

levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction

Other names: Group Levo

milrinone at a dose of 50 mcg/kg

Drug

milrinone will be administered via inhalation at a dose of 50 mcg/kg after anesthesia induction

Other names: Group Milri

Primary outcomes

  1. change from baseline in mean pulmonary arterial pressure (MPAP)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  2. change from baseline in pulmonary vascular resistance (PVR)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  3. change from baseline in mean arterial pressure (MAP)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  4. change from baseline in systemic vascular resistance (SVR)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  5. change from baseline in pulmonary capillary wedge pressure (PCWP)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  6. change from baseline in cardiac output (CO)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  7. change from baseline in tricuspid annular plane systolic excursion (TAPSE)

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

  8. change from baseline in fractional area change

    Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

  9. length of ICU stay

    Time frame: postoperatively, an average period of 7-10 days

    duration of patient stay in ICU in days

  10. hospitalization time

    Time frame: postoperatively, up to 20 days after the operation

    duration of hospital stay after surgery in days

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

Comparison of Intravenous Levosimendan and Inhalational Milrinone in High Risk Cardiac Patients With Pulmonary Hypertension

Acronym: levos-milr

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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