drugset / Trial / NCT03876041

Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome

NCT03876041 ↗

Phase 4 Completed 60 enrolled Assiut University
RandomizedParallel-groupOpen-labelOther

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

Drugs

EvaluationDrugModalityDoseRoute
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