PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

• Conditions: Obesity; Poisoning
• Interventions: Other: Anthropomorphism; Other: Relevant clinical datas

• Registration Number: NCT04850014
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20
• Primary Completion: 2021-05
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

• < 10 year old
• lack of data-

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Poisoned patients	Anthropomorphism	All subjects with paracetamolemia in the context of paracetamol poisoning
Poisoned patients	Relevant clinical datas	All subjects with paracetamolemia in the context of paracetamol poisoning
Control group	Relevant clinical datas	Acetaminophen-poisoned patient being non-obese
Control group	Anthropomorphism	Acetaminophen-poisoned patient being non-obese

Primary Outcome Measures

Name	Time	Method
Acetaminophen concentration	31 october 2021	With hour post-ingestion provided

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France