drugset / Trial / NCT02836899
Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
Phase 3
Completed
250 enrolled
Massachusetts General Hospital
Bonventre, Joseph V., M.D., Brigham Women Hospital · collabIchinose, Fumito, M.D., Ph.D., Massachusetts General Hospital · collabKacmarek, Robert M., Ph.D., Massachusetts General Hospital · collabKenneth, Shelton, M.D., Massachusetts General Hospital · collabMarrazzo, Francesco, M.D., Massachusetts General Hospital · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabRezoagli, Emanuele, M.D., Massachusetts General Hospital · collabShann, Kenneth G., Massachusetts General Hospital · collabSpina, Stefano, M.D., Massachusetts General Hospital · collabSundt, Thoralf M., M.D., Massachusetts General Hospital · collabThompson, Boyd Taylor, M.D., Massachusetts General Hospital · collabVillavicencio-Theoduloz, Mauricio A., M.D., Massachusetts General Hospital · collabZadek, Francesco, M.D., Massachusetts General Hospital · collabZapol, Warren M., M.D. · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.
Timeline
- Start
- 2017-02-08
- Primary completion
- 2025-08-15
- Completion
- 2025-08-15
Outcome
Missed primary endpoint
paper CONCLUSIONS: In cardiac surgery patients with preexisting endothelial dysfunction undergoing prolonged CPB, perioperative administration of 80 ppm nitric oxide for 24 h did not significantly reduce postoperative AKI. PMID 41270263 ↗
paper AKI occurred in 55 (44.0%) patients in the nitric oxide group and 54 (43.2%) patients in the control group (adjusted odds ratio, 1.00; 95% CI, 0.59 to 1.69). PMID 41270263 ↗
Publications
- Arora P, Di Fenza R, Shetty NS, Giammatteo V, Marrazzo F, Spina S, Zadek F, Gianni S, Fakhr BS, La Vita C, Shann K, Zheng H, Gaonkar M, Yu B, Feelisch M, Thompson TB, Akeju O, Sundt TM, Bonventre J, Ichinose F, Berra L; Cardiac Anesthesia Research Group. Nitric Oxide to Reduce Acute Kidney Injury in Patients with Preexisting Endothelial Dysfunction Requiring Prolonged Cardiopulmonary Bypass: A Randomized Clinical Trial. Anesthesiology. 2026 Mar 1;144(3):652-665. doi: 10.1097/ALN.0000000000005861. Epub 2025 Nov 21.
- Marrazzo F, Spina S, Zadek F, Lama T, Xu C, Larson G, Rezoagli E, Malhotra R, Zheng H, Bittner EA, Shelton K, Melnitchouk S, Roy N, Sundt TM, Riley WD, Williams P, Fisher D, Kacmarek RM, Thompson TB, Bonventre J, Zapol W, Ichinose F, Berra L. Protocol of a randomised controlled trial in cardiac surgical patients with endothelial dysfunction aimed to prevent postoperative acute kidney injury by administering nitric oxide gas. BMJ Open. 2019 Jul 4;9(7):e026848. doi: 10.1136/bmjopen-2018-026848.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 80 ppm | Inhaled |