drugset / Trial / NCT05402553

The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

NCT05402553

Phase 1/2 Unknown 40 enrolled Noha Mansour
RandomizedParallel-groupDouble-blindTreatment

Summary

Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.

Timeline

Start
2022-04-24
Primary completion
2023-06
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 8 mg Intravenous