Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

Anesthesia Clinical Trial

Official title:

Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132153
• Other study ID #: FAMSU R 174/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: October 17, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: Samar Soliman
• Phone: 01006236494
• Email: dr_sm.md[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.

Description:

The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 20, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility criteria:

• elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery).

• All surgery should be with CPB.

• All patients will be diagnosed with preoperative PH. PH was defined as a mean pulmonary artery pressure (MPAP) 30 mmHg or a systolic pulmonary artery pressure (SPAP) 40 mmHg, measured during preoperative right-sided catheterization or estimated by using doppler transthoracic echocardiography.

Exclusion Criteria:

• Cardiac surgery without CPB.

• Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).

• Adult congenital heart disease planned for corrective surgery.

• Contraindication to transesophageal echocardiography (TEE).

• Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Milrinone
will be given by nebulization
• Normal saline
will be given by nebuliztion

Locations

Country	Name	City	State
Egypt	Samar Soliman	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of inhaled milrinone on improvement of right ventricular function	The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)	After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit