Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome
Summary
Cardiac surgery and cardiopulmonary bypass (CPB) initiate a whole-body systemic inflammatory response (SIRS) characterized by the activation of leukocytes, monocytes, and the complement cascade. Multiple mediators of the inflammatory process are released, including cytokines, endothelin, adhesion molecules, and oxygen free radicals. An exaggerated release of these mediators may contribute to numerous postoperative end-organ complications, including myocardial dysfunction, neurologic impairment, respiratory failure, altered renal and hepatic function, bleeding disorders, and multiple organ failure. Although most cardiac surgical patients do not experience major adverse events, it is likely that the inflammatory response impairs clinical recovery to some degree in all patients. A large number of therapeutic strategies have been developed to attenuate the inflammatory reaction to CPB and thereby enhance recovery of the cardiac surgical patient. Intraoperative corticosteroid administration has been studied extensively as a primary pharmacologic anti-inflammatory treatment option.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2020-09-01
- Completion
- 2020-11-01
Publications
- Background Cicarelli DD, Bensenor FE, Vieira JE. Effects of single dose of dexamethasone on patients with systemic inflammatory response. Sao Paulo Med J. 2006 Mar 2;124(2):90-5. doi: 10.1590/s1516-31802006000200008.
- Background Wang D, Tang M, Zong P, Liu H, Zhang T, Liu Y, Zhao Y. MiRNA-155 Regulates the Th17/Treg Ratio by Targeting SOCS1 in Severe Acute Pancreatitis. Front Physiol. 2018 Jun 8;9:686. doi: 10.3389/fphys.2018.00686. eCollection 2018.
- Background Bocsi J, Hanzka MC, Osmancik P, Hambsch J, Dahnert I, Sack U, Bellinghausen W, Schneider P, Janousek J, Kostelka M, Tarnok A. Modulation of the cellular and humoral immune response to pediatric open heart surgery by methylprednisolone. Cytometry B Clin Cytom. 2011 Jul-Aug;80(4):212-20. doi: 10.1002/cyto.b.20587. Epub 2011 Mar 4.
- Background Schadenberg AW, Vastert SJ, Evens FC, Kuis W, van Vught AJ, Jansen NJ, Prakken BJ. FOXP3+ CD4+ Tregs lose suppressive potential but remain anergic during transient inflammation in human. Eur J Immunol. 2011 Apr;41(4):1132-42. doi: 10.1002/eji.201040363. Epub 2011 Mar 7.
- Background Soltani G, Abbasi Tashnizi M, Moeinipour AA, Ganjifard M, Esfahanizadeh J, Sepehri Shamloo A, Purafzali Firuzabadi SJ, Zirak N. Comparing the effect of preoperative administration of methylprednisolone and its administration before and during surgery on the clinical outcome in pediatric open heart surgeries. Iran Red Crescent Med J. 2013 Jun;15(6):483-7. doi: 10.5812/ircmj.8105. Epub 2013 Jun 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 0.1 mg/kg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 0.3 mg/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 5 mg/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 10 mg/kg | Intravenous |