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Not Yet RecruitingNCT07144267

Comparison of Milrinone and Epinephrine on TAPSE

Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
102 (estimated)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.

Detailed description

Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (\<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis. Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.

Conditions

Interventions

TypeNameDescription
DRUGEpinephrineNormal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping
DRUGMilrinone InjectionMilrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping

Timeline

Start date
2026-03-01
Primary completion
2027-12-30
Completion
2028-03-30
First posted
2025-08-27
Last updated
2026-02-25

Source: ClinicalTrials.gov record NCT07144267. Inclusion in this directory is not an endorsement.