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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-24

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

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

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ondansetron

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No