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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05402553

Enrollment

Registered

2022-06-02

Start date

2022-04-24

Completion date

2023-06-30

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Brief 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.

Interventions

DRUGOndansetron

patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days

DRUGPlacebo

patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactNoha Mansour

nohamansaur@mans.edu.eg0020403315353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026