PBPK Modelling Applied to Acetaminophen Poisoned Obese Children (IntoxPara)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Poisoning
• Intervention / Treatment: Other: Anthropomorphism; Other: Relevant clinical datas

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Kim An NGUYEN, MD; Phone Number: +33 4 72 31 94 11; Email: kim-an.nguyen@chu-lyon.fr
• Study Contact Backup: Name: Sébastien RIVAS; Phone Number: +33 6 43 09 51 20; Email: sebastien.rivas.1@gmail.com

Study Locations

• France
  • Lyon, France, 69000
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Kim An NGUYEN, MD; Phone Number: +33 4 72 31 94 11; Email: kim-an.nguyen@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Poisoned acetaminophen subjects
• At least one acetaminophen blood sample result available in data base

Description

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-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Poisoned patients; All subjects with paracetamolemia in the context of paracetamol poisoning	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.
Control group; Acetaminophen-poisoned patient being non-obese	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Pharmacokinetics; Pediatrics; Acetaminophen; Paracetamol; Poisoning; Modelling; Toxicokinetics; PBPK
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: 69HCL20_1244

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No