PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04850014

Acronym

IntoxPara

Enrollment

300

Registered

2021-04-20

Start date

2021-01-01

Completion date

2021-10-31

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Poisoning

Keywords

PBPK, Modelling, Acetaminophen, Paracetamol, Pediatrics, Obesity, Pharmacokinetics, Toxicokinetics, Poisoning

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.

Interventions

OTHERAnthropomorphism

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

OTHERRelevant 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

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-

Design outcomes

Primary

Measure	Time frame	Description
Acetaminophen concentration	31 october 2021	With hour post-ingestion provided

Countries

France

Contacts

Primary ContactKim An NGUYEN, MD

kim-an.nguyen@chu-lyon.fr4 72 31 94 11

Backup ContactSébastien RIVAS

sebastien.rivas.1@gmail.com6 43 09 51 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026