Clinical trial

Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension

Name

annie-panagiotis

Description

The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.

Trial arms

Trial start

2020-10-17

Estimated PCD

2022-10-17

Trial end

2022-10-17

Status

Completed

Treatment

levosimendan at a dose of 3 mcg/kg

levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction

Arms:

levosimendan administration at a dose of 3 mcg/kg after anesthesia induction

levosimendan at a dose of 6 mcg/kg

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

Arms:

levosimendan administration at a dose of 6 mcg/kg after anesthesia induction

levosimendan at a dose of 12 mcg/kg

levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction

Arms:

levosimendan administration at a dose of 12 mcg/kg after anesthesia induction

Size

Primary endpoint

change from baseline in mean pulmonary arterial pressure (MPAP)

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

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': 45, 'type': 'ACTUAL'}}

Updated at

2023-02-08

1 organization

1 product

4 indications

Organization

Aretaieion University Hospital

Product

Indication

Indication

Indication

Indication

Abnormalities of Pulmonary Vascular Resistance