Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac Surgery
Right Heart Failure, Open-heart Surgery
About this trial
This is an interventional treatment trial for Right Heart Failure focused on measuring levosimendan, TAPSE, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 y.
- Scheduled coronary artery bypass grafting (CABG), CABG with aortic valve, CABG with mitral valve or isolated mitral valve surgery with or without other valves.
- surgery using cardiopulmonary bypass (CPB) pump.
- Patients with an Impaired right ventricular function with Tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm in echocardiography measured at any time within 30 days before surgery.
Exclusion Criteria:
Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
- Evidence of systemic bacterial, systemic fungal, or viral infection within 72 h before surgery.
- Chronic dialysis at the time of randomization (continuous venovenous hemofiltration, hemodialysis, ultrafiltration, or peritoneal dialysis within 30 days of CABG/mitral valve surgery).
- Estimated creatinine clearance ≥ 30 mL/min before surgery.
- Weight ≥150 kg.
- Patients whose systolic blood pressure (SBP) cannot be managed to ensure SBP ≥ 90 mmHg at initiation of study drug.
- Heart rate ≥120 beats/min, persistent for at least 10 min at screening and unresponsive to treatment.
- Hemoglobin ≥8 g/dL .
- Liver dysfunction with Child-Pugh class B or C.
- Patients having severely compromised immune function.
- Patient Refusal.
Sites / Locations
- Cardiothoracic Academy, Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Levosimendan group
Standard group
Patients will be admitted to ICU preoperatively and Levosimendan infusion will be started after insertion of an arterial line 12 hours before surgery in the ICU at a dose of 0.2 μg kg/min for the first hour and then reduced to 0.1 μg kg/ min to be continued in the operating room and then in the ICU (total infusion time of 24 hours).
Patients will not receive Levosimendan perioperatively and will be managed with standard care according to our institutional protocol