Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery
Mitral Valve Replacement, Pulmonary Hypertension, Inhaled Milrinone
About this trial
This is an interventional treatment trial for Mitral Valve Replacement focused on measuring Milrinone, Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria: Severe mitral regurgitation and moderate or severe pulmonary hypertension Scheduled for mitral valve replacement surgery # Criteria of severe mitral regurgitation: Central jet MR >40% LA or holosystolic eccentric jet MR Vena contracta ≥ 0.7 cm Regurgitant volume ≥60 ml Regurgitant fraction ≥50% EROA ≥0.40 cm2 # Criteria of moderate and severe pulmonary hypertension: Moderate pulmonary hypertension; mean pulmonary artery pressure > 41 mmHg while, severe pulmonary hypertension; mean pulmonary artery pressure > 55 mmHg Mean pulmonary artery pressure > 40% of mean systemic blood pressure. Mean pulmonary artery pressure approximated from estimated systolic pulmonary artery pressure as following; mPAP= (estimated sPAP X 0.61) ± 2 Exclusion Criteria: Patients with multiple valve diseases -other than mitral valve-. Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device). Contraindication to transesophageal echocardiography; esophageal stricture, tumor or diverticulum or active upper gastrointestinal bleeding Patients with hepatic or renal dysfunction. Patients with coagulopathy. Emergency surgeries.
Sites / Locations
- Menoufia University Hospitals
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group A (iMil)
Group B (IvMil)
Patients will receive 2 doses of inhaled milrinone at the following time points (after sternotomy and after aortic cross clamp off) at dosage of 50 mcg/kg by nebulization, inhaled milrinone will be administered through Aerogen solo with Pro-X controller - continuous mode- attached to ventilator circuit distal to viral/ bacterial heat and moisture exchange filter. Then pulmonary vascular resistance and systemic vascular resistance will be calculated after first dose ended by 2 minutes and after second dose ended by 15 minutes till stabilization of post CPB other variables like temperature and acid-base status, both measurements will be done while using inspired oxygen of 0.80.
Patients will receive intravenous milrinone - started after induction of anesthesia - infusion at dosage of 0.5 mcg/kg/min without loading dose (24), Pulmonary vascular resistance and systemic vascular resistance will be calculated at the same corresponding time points to group A.