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

• Sponsor: Noha Mansour (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05402553
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 7.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Septic Shock	Drug: Ondansetron; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock
• Actual Study Start Date: Apr 24, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention	Drug: Ondansetron; patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days
Placebo Comparator: Control	Drug: Placebo; patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days

Outcome Measures

Primary Outcome Measures

1. Sequential organ failure assessment (SOFA score) [3 days post randomization]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta		Egypt

Sponsors and Collaborators

• Noha Mansour

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Mansour, Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University
• ClinicalTrials.gov Identifier: NCT05402553
• Other Study ID Numbers: 16-2022
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock; Ondansetron

Study Results

No Results Posted as of Jun 2, 2022