Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective double blinded randomized study aims to compare the effect of inhaled versus intravenous milrinone on the pulmonary vascular resistance in patients undergoing mitral valve replacement surgery.

The primary outcome is to determine change in pulmonary artery pressure. The secondary outcomes include,

• Incidence of systemic hypotension.

• Hemodynamic affection and need of vasopressors and inotropes.

• Change in pulmonary vascular resistance versus systemic vascular resistance.

• Right ventricular function.

• Duration of mechanical ventilation.

• Need for mechanical circulatory support devices.

• Urine output

• Length of intensive care (ICU) in stay.

As the investigators hypothesize that inhaled milrinone has a selective pulmonary vasodilator effect devoid of the systemic hypotension with the intravenous administration.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menoufia University
• Treatments: Milrinone

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.