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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05132153
Enrollment
70
Registered
2021-11-24
Start date
2021-10-17
Completion date
2022-09-20
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGMilrinone

will be given by nebulization

DRUGNormal saline

will be given by nebuliztion

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of inhaled milrinone on improvement of right ventricular functionAfter 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unitThe right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)

Countries

Egypt

Contacts

Primary ContactSamar Soliman
dr_sm.md@hotmail.com01006236494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026