Treatment of Pulmonary Hypertension in High-risk Cardiac Surgery Patients Using Inhalational and Intravenous Agents
- Conditions
- Cardiac FailureHypertension, PulmonaryPulmonary Vascular Resistance Abnormality
- Interventions
- Registration Number
- NCT04718350
- Lead Sponsor
- Aretaieion University Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
- elective cardiac surgery
- primary pulmonary hypertension
- thromboembolic disease
- chronic obstructive pulmonary disease
- emergency surgery
- redo surgery
- inability to consent to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous administration of Levosimendan at a dosage of 6 mcg/kg after induction of anesthesia levosimendan at a dose of 6 mcg/kg in this group, 6 mcg/kg of levosimendan will be administered intravenously after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass Inhalational administration of Milrinone at a dosage of 50 mcg/kg after induction of anesthesia milrinone at a dose of 50 mcg/kg in this group, 50 mcg/kg of milrinone will be administered via inhalation after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
- Primary Outcome Measures
Name Time Method 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 a Swan-Ganz catheter will be used for hemodynamic measurements
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 a Swan-Ganz catheter will be used for hemodynamic measurements
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 a Swan-Ganz catheter will be used for hemodynamic measurements
length of ICU stay postoperatively, an average period of 7-10 days duration of patient stay in ICU in days
hospitalization time postoperatively, up to 20 days after the operation duration of hospital stay after surgery in days
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 transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
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 a Swan-Ganz catheter will be used for hemodynamic measurements
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 a Swan-Ganz catheter will be used for hemodynamic measurements
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 a Swan-Ganz catheter will be used for hemodynamic measurements
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 transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Onassis Cardiac Surgery Center
🇬🇷Athens, Greece