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