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

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Milrinone; Drug: Normal saline

• Registration Number: NCT05132153
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-17
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Group A) will receive milrinone	Milrinone	Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization
(Group B) will receive normal saline	Normal saline	Patients will receive 5 ml saline by nebulization over 5 min

Primary Outcome Measures

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

Trial Locations

Locations (1)

Samar Soliman; 🇪🇬 Cairo, Nasr City, Egypt