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

N

Noha Mansour

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Septic Shock
Sepsis

Treatments

Drug: Ondansetron
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05402553
16-2022

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Treatment:
Drug: Ondansetron
Control
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Noha Mansour

Data sourced from clinicaltrials.gov

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