Clinical trial

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

Name

16-2022

Description

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.

Trial arms

Trial start

2022-04-24

Estimated PCD

2023-06-01

Trial end

2023-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Ondansetron

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

Arms:

Intervention

Placebo

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

Arms:

Control

Size

Primary endpoint

Sequential organ failure assessment (SOFA score)

3 days post randomization

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-03-15

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug