跳至主要内容
临床试验/NCT05402553
NCT05402553招募中1 期

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

Noha Mansour1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Sequential organ failure assessment (SOFA score)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Intervention

Active Comparator

干预措施: Ondansetron (Drug)

Control

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Sequential organ failure assessment (SOFA score)

时间窗: 3 days post randomization

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

次要结局

未报告次要终点

研究者

发起方
Noha Mansour
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Noha Mansour

Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Mansoura University

研究点 (1)

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