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

Primary Purpose

Sepsis, Septic Shock

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ondansetron
Placebo
Sponsored by
Noha Mansour
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tanta University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Sequential organ failure assessment (SOFA score)
Difference between study groups in mean change from baseline in SOFA score

Secondary Outcome Measures

Full Information

First Posted
May 30, 2022
Last Updated
March 13, 2023
Sponsor
Noha Mansour
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1. Study Identification

Unique Protocol Identification Number
NCT05402553
Brief Title
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock
Official Title
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Noha Mansour

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days
Primary Outcome Measure Information:
Title
Sequential organ failure assessment (SOFA score)
Description
Difference between study groups in mean change from baseline in SOFA score
Time Frame
3 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Mansour
Phone
0020403315353
Email
nohamansaur@mans.edu.eg
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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