Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Pulmonary Hypertension Due to Left Heart Disease Clinical Trial

Official title:

Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484675
• Other study ID #: milrinone in cardiadc surgery
• Status: Recruiting
• Phase: Phase 4
• Start date: January 20, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2023
• Source: Zagazig University
• Contact: Heba M EL-Asser, MD
• Phone: 01062393152
• Email: aseelaswad1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (de?ned 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

Related Conditions & MeSH terms

• Heart Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension Due to Left Heart Disease

Intervention

Drug:
• Milrinone inhalation
After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
• Milrinone infusion
After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 µg/kg/min)infusion are administered

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial pressure	The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone	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	mean pulmonary arterial pressure	The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone	change in mean pulmonary arterial pressure 10 minutes after milrinone administration
Secondary	systemic vascular resistance	The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone	change in systemic vascular resistance 10 minutes after milrinone administration
Secondary	pulmonary vascular resistance	The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone	change in pulmonary vascular resistance 10 minutes after milrinone administration