drugset / Trial / NCT03009643
Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
RandomizedParallel-groupSingle-blindTreatment
Summary
Hypoxemia is a common complication after aortic surgery. As this complication has an adverse effect on the postoperative course of the patient, early treatment is important; however, the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of these patients. The investigators are trying to evaluate the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
Timeline
- Start
- 2016-10
- Primary completion
- 2019-10
- Completion
- 2019-12
Publications
- Background Garcia-Delgado M, Navarrete-Sanchez I, Colmenero M. Preventing and managing perioperative pulmonary complications following cardiac surgery. Curr Opin Anaesthesiol. 2014 Apr;27(2):146-52. doi: 10.1097/ACO.0000000000000059.
- Background Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312.
- Background Griffiths MJ, Evans TW. Inhaled nitric oxide therapy in adults. N Engl J Med. 2005 Dec 22;353(25):2683-95. doi: 10.1056/NEJMra051884. No abstract available.
- Results Nakajima T, Kawazoe K, Izumoto H, Kataoka T, Niinuma H, Shirahashi N. Risk factors for hypoxemia after surgery for acute type A aortic dissection. Surg Today. 2006;36(8):680-5. doi: 10.1007/s00595-006-3226-5.
- Results Wang Y, Xue S, Zhu H. Risk factors for postoperative hypoxemia in patients undergoing Stanford A aortic dissection surgery. J Cardiothorac Surg. 2013 Apr 30;8:118. doi: 10.1186/1749-8090-8-118.
- Results Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6. doi: 10.1038/327524a0.
- Results Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. doi: 10.1161/01.cir.83.6.2038.
- Results Frostell CG, Blomqvist H, Hedenstierna G, Lundberg J, Zapol WM. Inhaled nitric oxide selectively reverses human hypoxic pulmonary vasoconstriction without causing systemic vasodilation. Anesthesiology. 1993 Mar;78(3):427-35. doi: 10.1097/00000542-199303000-00005.
- Results Benedetto M, Romano R, Baca G, Sarridou D, Fischer A, Simon A, Marczin N. Inhaled nitric oxide in cardiac surgery: Evidence or tradition? Nitric Oxide. 2015 Sep 15;49:67-79. doi: 10.1016/j.niox.2015.06.002. Epub 2015 Jul 14.
- Results Clark RH, Kueser TJ, Walker MW, Southgate WM, Huckaby JL, Perez JA, Roy BJ, Keszler M, Kinsella JP. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000 Feb 17;342(7):469-74. doi: 10.1056/NEJM200002173420704.
- Results Cornfield DN, Maynard RC, deRegnier RA, Guiang SF 3rd, Barbato JE, Milla CE. Randomized, controlled trial of low-dose inhaled nitric oxide in the treatment of term and near-term infants with respiratory failure and pulmonary hypertension. Pediatrics. 1999 Nov;104(5 Pt 1):1089-94. doi: 10.1542/peds.104.5.1089.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 5 ppm | Inhaled |
| Subject | Nitric Oxide | Other / unclassified | 10 ppm | Inhaled |
Indications
No indication recorded.