Clinical trial NCT04484675: Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension
Official title: Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pulmonary Hypertension Due to Left Heart Disease
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-07-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Detailed description: Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs

The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =\>55 estimated by using preoperative Doppler echocardiography

Exclusion Criteria:

Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (deﬁned as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease

, coagulopathy, and thromboembolic disease treated with anticoagulants

Primary outcomes:
measure: mean arterial pressure
timeFrame: change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)
Secondary outcomes:
measure: mean pulmonary arterial pressure
timeFrame: change in mean pulmonary arterial pressure 10 minutes after milrinone administration
measure: systemic vascular resistance
timeFrame: change in systemic vascular resistance 10 minutes after milrinone administration
measure: pulmonary vascular resistance
timeFrame: change in pulmonary vascular resistance 10 minutes after milrinone administration
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Heba M EL-Asser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
citation: Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16.