The NITRIC Randomized Clinical Trial

Now the the international NITRIC trial that is Nitric Oxide During Cardiopulmonary Bypass to Improve Recovery in Infants With Congenital Heart Defects was conducted to test the hypothesis that nitric oxide applied into the cardiopulmonary bypass oxygenator would result in more ventilator-free days than standard care in children undergoing surgery for congenital heart disease.

The study was published in JAMA Network.      

It was a double-blind, multicenter, randomized clinical trial conducted in 6 pediatric cardiac surgical centers. A total of 1371 children younger than 2 years undergoing congenital heart surgery were randomized, with 28-day follow-up period.

Patients were assigned to receive nitric oxide at 20 ppm delivered into the cardiopulmonary bypass oxygenator or standard care cardiopulmonary bypass without nitric oxide. The primary end point was the number of ventilator-free days from commencement of bypass until day 28 there were 4 secondary end points including a composite of low cardiac output syndrome, extracorporeal life support, or death; length of stay in the ICU; length of stay in the hospital; and postoperative troponin levels.

It was found that a total of 22.5% of the nitric oxide group and 20.9% of the standard care group developed low cardiac output syndrome within 48 hours, needed extracorporeal support within 48 hours, or died by day 28.

Therefore, the authors concluded that these findings do not support the use of nitric oxide delivered into the cardiopulmonary bypass oxygenator during heart surgery meaning that among infants undergoing heart surgery, delivery of nitric oxide into the cardiopulmonary bypass did not increase ventilator-free survival censored at 28 days.

Reference:

Schlapbach LJ, Gibbons KS, Horton SB, et al. Effect of Nitric Oxide via Cardiopulmonary Bypass on Ventilator-Free Days in Young Children Undergoing Congenital Heart DiseaseSurgery: The NITRIC Randomized Clinical Trial. JAMA. Published online June 27, 2022. doi:10.1001/jama.2022.9376