Clinical trial

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

ID

Name

levo-milri

Description

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.

Trial arms

Trial start

2021-01-27

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Recruiting

Treatment

levosimendan at a dose of 6 mcg/kg

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

Arms:

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

Other names:

Group Levo

milrinone at a dose of 50 mcg/kg

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

Arms:

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

Other names:

Group Milri

Size

40

Primary endpoint

change from baseline in mean pulmonary arterial pressure (MPAP)

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

change from baseline in pulmonary vascular resistance (PVR)

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

change from baseline in mean arterial pressure (MAP)

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

change from baseline in systemic vascular resistance (SVR)

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

change from baseline in pulmonary capillary wedge pressure (PCWP)

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

change from baseline in cardiac output (CO)

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

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

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

change from baseline in fractional area change

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

length of ICU stay

postoperatively, an average period of 7-10 days

hospitalization time

postoperatively, up to 20 days after the operation

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-02-24

1 organization

2 products

4 indications

Organization

Aretaieion University Hospital

Product

Indication

Indication

Indication

Indication

Abnormalities of Pulmonary Vascular Resistance

Product