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The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock - Trial NCT05402553

Access comprehensive clinical trial information for NCT05402553 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Noha Mansour and is currently Recruiting. The study focuses on Sepsis,Septic Shock. Target enrollment is 40 participants.

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NCT05402553
Phase 1/2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05402553
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The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Study Focus

Sepsis,Septic Shock

Ondansetron

Interventional

drug

Sponsor & Location

Noha Mansour

Mansoura University

Tanta, Egypt

Timeline & Enrollment

Phase 1/2

Apr 24, 2022

Oct 01, 2022

40 participants

Primary Outcome

Sequential organ failure assessment (SOFA score)

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.

ICD-10 Classifications

Septic shock
Other sepsis
Other specified sepsis
Sepsis, unspecified
Sepsis due to other specified staphylococcus

Data Source

ClinicalTrials.gov

NCT05402553

Non-Device Trial