Study of Inhaled Milrinone and Epoprostenol to Improve Outcomes in Adults Undergoing Cardiac Surgery with Bypass

What this Trial Is About

This research focuses on patients undergoing cardiac surgery with cardiopulmonary bypass CPB who have pulmonary hypertension PH or right ventricular dysfunction. The study is a randomized, double-blind, controlled clinical trial evaluating whether inhaled epoprostenol combined with milrinone can improve outcomes during the transition off CPB. Pulmonary hypertension and right ventricular dysfunction are linked to increased risks such as longer mechanical ventilation, extended hospital stays, and higher mortality, making improved management important. Participants will be randomly assigned to receive either a combination of inhaled epoprostenol and milrinone or a placebo before the start of CPB. The inhaled treatments are delivered via an ultrasonic nebulizer over 20 minutes. The experimental group receives 4mg of milrinone and 60 mcg of epoprostenol, while the control group receives saline. The study aims to compare the rate of difficult CPB weaning, defined by the need for inotropes, vasopressors, mechanical support, or return to bypass. During the trial, patients will be monitored for hemodynamic stability and clinical outcomes including vasopressor and inotrope use, duration of organ dysfunction, and length of ICU stay. Various hemodynamic parameters and postoperative complications will be assessed for up to one year. The total participant involvement covers the perioperative and postoperative period to evaluate the impact of the inhaled combination therapy on cardiac surgery recovery.

Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation