NCT05402553

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Noha Mansour · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	Ondansetron	patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days
DRUG	Placebo	patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days

Timeline

• Start date: 2022-04-24
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-06-02
• Last updated: 2023-03-15

Locations

1 site across 1 country: Egypt