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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402553
• Other study ID #: 16-2022
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 24, 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2023
• Source: Mansoura University
• Contact: Noha Mansour
• Phone: 0020403315353
• Email: nohamansaur[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

male or female adult patients, aged 18 years or older with sepsis or septic shock after surgery according to the 2016 third international consensus definitions for sepsis and septic shock Exclusion Criteria: diagnosis of septic shock longer than 24 hours ago known or suspected disease with a strong indication or contraindication for the study drugs Pregnant and lactating women.

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Drug:
• Ondansetron
patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days
• Placebo
patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Noha Mansour

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sequential organ failure assessment (SOFA score)	Difference between study groups in mean change from baseline in SOFA score	3 days post randomization