Inhaled nitric oxide and prevention of pulmonary hypertension after congenital heart surgery: a randomised double-blind study

• Published in: The Lancet (British edition) 2000-10, Vol.356 (9240), p.1464-1469
• Main Authors: Miller, Owen I, Tang, Swee Fong, Keech, Anthony, Pigott, Nicholas B, Beller, Elaine, Celermajer, David S
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Anesthesia; Antihypertensive agents; Biological and medical sciences; Cardiovascular disease; Cardiovascular diseases; Cardiovascular system; Clinical trials; Congenital diseases; Coronary artery disease; Defects; Double-Blind Method; Double-blind studies; Endothelium; Extubation; Female; Gases; Heart Defects, Congenital - physiopathology; Heart Defects, Congenital - surgery; Heart diseases; Heart surgery; Humans; Hypertension; Hypertension, Pulmonary - physiopathology; Hypertension, Pulmonary - prevention & control; Infant; Infant, Newborn; Infants; Intensive care; Lung - blood supply; Male; Medical research; Medical sciences; Morbidity; Mortality; Motivation; Neonates; Nitric oxide; Nitric Oxide - administration & dosage; Nitric Oxide - therapeutic use; Nitrogen; Nitrogen dioxide; Patients; Pharmacology. Drug treatments; Preventive medicine; Pulmonary arteries; Pulmonary hypertension; Randomization; Respiratory therapy; Risk; Surgery; Treatment Outcome; Vascular Resistance - drug effects; Veins & arteries; Ventilators; Ventricle; Weaning
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(00)02869-5

Pulmonary hypertensive crises (PHTC) are a major cause of morbidity and mortality after congenital heart surgery. Inhaled nitric oxide is frequently used as rescue therapy. We did a randomised double-blind study to investigate the role of routinely administered inhaled nitric oxide to prevent pulmonary hypertension in infants at high risk. We enrolled 124 infants (64 male, 60 female; median age 3 months [IQR 1–5]), 76% with large ventricular or atrioventricular septal defects, who had high pulmonary flow, pressure, or both, and were undergoing corrective surgery for congenital heart disease. They were randomly assigned continuous low-dose inhaled nitric oxide (n=63) or placebo (n=61) from surgery until just before extubation. We measured the numbers of PHTC, time on study gas, and hours spent in intensive care. Analysis was done by intention to treat. Compared with placebo, infants receiving inhaled nitric oxide had fewer PHTC (median four [IQR 0–12] vs seven [1–19]; relative risk, unadjusted 0·66, p