Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery

Phase

2/3

Condition

Pulmonary Arterial Hypertension

Williams Syndrome

Congestive Heart Failure

Treatment

Inhaled Milrinone

IV Milrinone

Clinical Study ID

NCT05838846

2/2023 ANET 60

Ages 18-60
All Genders

Study Summary

This prospective open-label 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Severe mitral regurgitation and moderate or severe pulmonary hypertension
Scheduled for mitral valve replacement surgery
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
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 arterypressure as following; mPAP= (estimated sPAP X 0.61) ± 2

Exclusion

Exclusion Criteria:

Patients with aortic valvular lesions or pulmonary stenosis.
Hemodynamic instability in the preoperative time (defined as acute requirement forvasoactive support or mechanical device).
Contraindication to transesophageal echocardiography; esophageal stricture, tumor ordiverticulum or active upper gastrointestinal bleeding
Patients with hepatic or renal dysfunction.
Patients with coagulopathy.
Emergency surgeries.

Study Design

Inhaled Milrinone

2/3

April 01, 2023

January 01, 2025

Study Description

All patients underwent standard preoperative cardiac surgery assessment. Premedication included bromazepam and ranitidine, given the night before and 2 hours prior to arrival to OT. On arrival, IV access and arterial cannula were inserted under local anesthesia, along with routine monitoring electrocardiogram (ECG), pulse oximetery (SpO2), and IBP.

Anesthesia was induced with midazolam, fentanyl, and cis-atracurium. After tracheal intubation, ultrasound (US) guided- central venous catheter (CVC) was inserted and TEE also applied and then anesthesia maintained with morphine, cis-atracurium infusions, and sevoflurane. Mechanical ventilation was set to maintain end-tidal carbon dioxide (etco2) in the range of 30-40 mmHg using lung protective ventilation strategies.

During CPB, flow of 2.2 L.min-1.m-2, a custodiol cardioplegia was given, temperature kept at 28-32℃ and anesthesia maintained by sevoflurane- through a vaporizer mounted on CPB machine-.

A senior consultant certified cardiac anesthetist conducted a baseline TEE using Philips EPIQ CVxi echocardiography machine. Baseline measures included left ventricular ejection fraction (LVEF), and RV function represented by tricuspid annulus plane systolic excursion (TAPSE), fractional area changes (FAC), and right ventricular systolic pressure (RVSP) by doppler also, PVR and systemic vascular resistance (SVR) was calculated, plus patients hemodynamics (mean arterial blood pressure (MAP), heart rate (HR)), all measures were recorded.

Connect with a study center

Menoufia University Hospitals
Shibīn Al Kawm, Menoufia
Egypt
Site Not Available

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