Cardiac Failure, Hypertension, Pulmonary, Pulmonary Vascular Resistance Abnormality
Conditions
Keywords
pulmonary vascular resistance, pulmonary hypertension, vasodilators, milrinone, levosimendan, cardiopulmonary bypass
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.
Interventions
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
DRUGmilrinone at a dose of 50 mcg/kg
milrinone will be administered via inhalation at a dose of 50 mcg/kg after anesthesia induction
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 |
| 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 |
| 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 |
Countries
Greece
Outcome results
None listed