PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Poisoning, Obesity

Intervention / Treatment
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* Other: Anthropomorphism
* Other: Relevant clinical datas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects >/= 10 year old Availability of at least one positive acetaminophen concentration with its associated sampling time Known clinical outcome Exclusion Criteria: < 10 year old lack of data-

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Poisoned patients<br>All subjects with paracetamolemia in the context of paracetamol poisoning | Other: Anthropomorphism<br>* Height, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender<br>Other: Relevant clinical datas<br>* Medical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation. Imaging.<br>|
| Control group<br>Acetaminophen-poisoned patient being non-obese | Other: Anthropomorphism<br>* Height, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender<br>Other: Relevant clinical datas<br>* Medical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation. Imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetaminophen concentration | With hour post-ingestion provided | 31 october 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Paracetamol, Pediatrics, Obesity, Pharmacokinetics, Toxicokinetics, Poisoning, PBPK, Modelling