drugset / Trial / NCT03748082
Effects of Nitric Oxide on the Endothelium During Hemolysis.
Phase 2
Withdrawn
Massachusetts General Hospital
Jennifer En-Sian Ho M.D., Massachusetts General Hospital · collabMarrazzo, Francesco, M.D., Massachusetts General Hospital · collabNaomi M Hamburg, M.D., Boston University · collabSpina, Stefano, M.D., Massachusetts General Hospital · collabZadek, Francesco, M.D., Massachusetts General Hospital · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.
Timeline
- Start
- 2018-12-05
- Primary completion
- 2023-11
- Completion
- 2023-11
Publications
- Background Lei C, Berra L, Rezoagli E, Yu B, Dong H, Yu S, Hou L, Chen M, Chen W, Wang H, Zheng Q, Shen J, Jin Z, Chen T, Zhao R, Christie E, Sabbisetti VS, Nordio F, Bonventre JV, Xiong L, Zapol WM. Nitric Oxide Decreases Acute Kidney Injury and Stage 3 Chronic Kidney Disease after Cardiac Surgery. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1279-1287. doi: 10.1164/rccm.201710-2150OC.
- Background Rezoagli E, Ichinose F, Strelow S, Roy N, Shelton K, Matsumine R, Chen L, Bittner EA, Bloch DB, Zapol WM, Berra L. Pulmonary and Systemic Vascular Resistances After Cardiopulmonary Bypass: Role of Hemolysis. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):505-515. doi: 10.1053/j.jvca.2016.06.009. Epub 2016 Jun 8.
- Background Tabit CE, Shenouda SM, Holbrook M, Fetterman JL, Kiani S, Frame AA, Kluge MA, Held A, Dohadwala MM, Gokce N, Farb MG, Rosenzweig J, Ruderman N, Vita JA, Hamburg NM. Protein kinase C-beta contributes to impaired endothelial insulin signaling in humans with diabetes mellitus. Circulation. 2013 Jan 1;127(1):86-95. doi: 10.1161/CIRCULATIONAHA.112.127514. Epub 2012 Nov 30.
- Background Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | — | Inhaled |