Pulmonary Hypertension Clinical Trial
Official title:
Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery
Verified date | March 2024 |
Source | Menoufia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 116 |
Est. completion date | March 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Menoufia University Hospitals | Shibin Al Kawm | Menoufia |
Lead Sponsor | Collaborator |
---|---|
Menoufia University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pulmonary artery pressure | Intraoperative | ||
Secondary | Incidence of systemic hypotension | Intraoperative and postoperative in ICU (up to 24 hours) | ||
Secondary | Hemodynamic affection and need of vasopressors and inotropes. | Intraoperative and postoperative in ICU (up to 24 hours) | ||
Secondary | Pulmonary vascular resistance versus systemic vascular resistance | Systemic vascular resistance: (MAP-CVP) x 80 / CO
Pulmonary vascular resistance = (MPAP-LAP) X 80 / CO |
Intraoperative and postoperative in ICU (up to 24 hours) | |
Secondary | Right ventricular function | Measured by tricuspid annulus plane systolic excursion, fractional area changes, and right ventricular systolic pressure by doppler | Intraoperative and postoperative in ICU (up to 24 hours) | |
Secondary | Duration of mechanical ventilation | Intraoperative and postoperative in ICU (up to 24 hours) | ||
Secondary | Need for mechanical circulatory support devices | Intraoperative and postoperative in ICU (up to 24 hours) | ||
Secondary | Urine output | Intraoperative and postoperative in ICU (up to 24 hours) | ||
Secondary | Length of intensive care (ICU) in stay | Intraoperative and postoperative in ICU (up to 24 hours) |
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