NCT04850014

PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Poisoning
• Obesity

Interventions

Type	Name	Description
OTHER	Anthropomorphism	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
OTHER	Relevant clinical datas	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-05-01
• Completion: 2021-10-01
• First posted: 2021-04-20
• Last updated: 2021-04-20

Locations

1 site across 1 country: France