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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-17

Study Completion Date

2022-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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(Group A) will receive milrinone

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

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

will be given by nebulization

(Group B) will receive normal saline

Patients will receive 5 ml saline by nebulization over 5 min

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

will be given by nebuliztion

Interventions

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Milrinone

will be given by nebulization

Intervention Type DRUG

Normal saline

will be given by nebuliztion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No