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

NCT05402553 | Unknown Phase 1

• 1 other identifier: 16-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Sequential organ failure assessment (SOFA score)

  Difference between study groups in mean change from baseline in SOFA score

  3 days post randomization

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Drug: Ondansetron

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ondansetron DRUG

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

Intervention

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noha Mansour: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Noha Mansour

CONTACT

0020403315353; nohamansaur@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: April 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

EG (1)