PBPK Modelling Applied to Acetaminophen Poisoned Obese Children (IntoxPara)

Civil Hospices of Lyon

Status: Unknown

Conditions: Obesity; Poisoning

Treatments: Other: Anthropomorphism; Other: Relevant clinical datas

Study type: Observational

Funder types: Other

Identifiers

NCT04850014

69HCL20_1244

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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-

Trial design

300 participants in 2 patient groups

Poisoned patients

Description:

All subjects with paracetamolemia in the context of paracetamol poisoning

Treatment:

Other: Anthropomorphism

Other: Relevant clinical datas

Control group

Description:

Acetaminophen-poisoned patient being non-obese

Treatment:

Other: Anthropomorphism

Other: Relevant clinical datas