跳至主要内容
临床试验/NCT04850014
NCT04850014Unknown不适用

Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Acetaminophen concentration

研究概览

简要总结

Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • All subjects >/= 10 year old
  • Availability of at least one positive acetaminophen concentration with its associated sampling time
  • Known clinical outcome

排除标准

  • < 10 year old
  • lack of data-

结局指标

主要结局

Acetaminophen concentration

时间窗: 31 october 2021

With hour post-ingestion provided

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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