Study of Inhaled Nitric Oxide to Reduce Serious Complications and Life Support Needs in Adults Undergoing Cardiac Surgery with Cardiopulmonary Bypass

What this Trial Is About

Cardiac surgery, often performed worldwide with the use of cardiopulmonary bypass CPB, remains a high-risk procedure due to complications such as acute kidney injury, respiratory failure, myocardial infarction, stroke, and cognitive dysfunction. Researchers are evaluating inhaled nitric oxide NO therapy as a selective pulmonary vasodilator to manage pulmonary hemodynamics and reduce life-threatening complications in high-risk cardiac surgery patients. This large multicenter randomized controlled trial aims to confirm the benefits of NO in reducing death and major adverse events after cardiac surgery with CPB. In this Phase III, double-blind, multicenter study, participants are randomly assigned to receive either inhaled NO gas or a control gas during and after cardiac surgery with CPB. The NO group receives 80 parts per million ppm of NO during CPB via the oxygenator, followed by 40-80 ppm of NO through the ventilator for up to 6 hours after ICU admission or until extubation. The control group receives standard care with 80 ppm nitrogen N2 added to the gas mixture or air without NO. The study investigates the effects of NO on reducing major adverse events and the need for intensive life support. Participants are monitored through 30 days after surgery for a composite outcome of death and major adverse events requiring intensive life support. Assessments include the number and incidence of major adverse events, acute kidney injury within 7 days, length of mechanical ventilation, ICU stay, hospital stays, and mortality up to one year. Additional evaluations involve organ-specific scores, hemolysis markers, and safety monitoring. The total participation duration includes follow-up assessments up to one year after surgery to evaluate long-term outcomes and safety.

Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass