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

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Anesthesia

Treatments: Drug: Normal saline; Drug: Milrinone

Study type: Interventional

Funder types: Other

Identifiers

NCT05132153

FAMSU R 174/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

(Group A) will receive milrinone

Active Comparator group

Description:

Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization

Treatment:

Drug: Milrinone

(Group B) will receive normal saline

Placebo Comparator group

Description:

Patients will receive 5 ml saline by nebulization over 5 min

Treatment:

Drug: Normal saline